Clinical Topic A-Z Clinical Speciality

Contraception - IUS/IUD

Contraception - IUS/IUD
D007434Intrauterine Devices
D003267Contraception
PregnancySexual healthWomen's health
2012-06-01Last revised in June 2012

Contraception - IUS/IUD - Summary

The contraceptive effects of the levonorgestrel-releasing intrauterine system (IUS) are mainly due to its progestogenic effect on the endometrium, which prevents implantation of the fertilized ovum. In addition, changes in cervical mucus inhibit penetration of sperm into the uterus.

The primary mode of action of copper intrauterine devices (IUDs) is via the toxic effects of copper on the ovum and sperm, preventing fertilization.

If a woman is considering using an intrauterine device (IUD or IUS):

Pregnancy should be excluded. If pregnancy is possible, the IUD or IUS should not be inserted. The use of a barrier method (such as condoms) should be advised until pregnancy can be excluded.

The UK Medical Eligibility Criteria should be checked to ensure that a woman can safely use an IUD or IUS.

Verbal and written information on the IUD or IUS should be given, including the advantages and disadvantages, efficacy, what to do if she is unable to feel the threads, and how to manage adverse effects (e.g. unscheduled bleeding).

The risk of sexually transmitted infections (STIs) should be assessed and when appropriate, testing should be advised along with promotion of safer sex, and/or referral for sexual health counselling. Correct and consistent use of condoms should be advised with an intrauterine device.

In young women and women with special needs, their competence to decide should be assessed, and support offered to help them make their own decisions about contraception.

If considering an IUD, a woman should be advised that:

It needs to be changed every 5–10 years (depending on which IUD is used).

It can be removed at any time if she wishes to become pregnant and there is no delay in return to fertility.

When inserted correctly, 6 out of 1000 women will conceive within the first year of use.

If considering an IUS, a woman should be advised that:

It needs to be changed every 5 years (although it can be left in for longer in certain cases).

It can be removed at any time if she wishes to become pregnant and there is no delay in return to fertility.

When inserted correctly, 1 out of 1000 women will conceive within the first year of use.

The Family Planning Association provides useful leaflets on the intrauterine methods of contraception (see www.fpa.org.uk).

Have I got the right topic?

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This CKS topic covers how to use the levonorgestrel-releasing intrauterine system and the copper–containing intrauterine device. It covers the advantages and disadvantages of these methods, the UK Medical Eligibility criteria, and their efficacy. It incorporates recommendations from guidelines published by the Faculty of Sexual and Reproductive Healthcare (FSRH), formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC), and from guidelines published by NICE.

This CKS topic does not cover how to fit copper intrauterine devices or the levonorgestrel-releasing intrauterine system. This is because specific training is required for each of these activities.

This CKS topic does not cover the management of women requesting emergency contraception, or other methods of contraception. There are separate CKS topics for these methods.

This CKS topic also does not cover the factors affecting the choice of contraceptive methods, such as co-morbidities, concurrent medication, age (perimenopause, young women) ethical and legal issues, safe sex advice, and assessment for sexually transmitted infections. There is a separate CKS topic which covers assessment for contraception.

There are separate CKS topics on Contraception - assessment, Contraception - barrier methods and spermicides, Contraception - combined hormonal methods, Contraception - emergency, Contraception - natural family planning, Contraception - progestogen-only methods, Contraception - sterilization, Amenorrhoea, Chlamydia - uncomplicated genital, Endometriosis, Infertility, Menorrhagia and Pre-conception - advice and management.

The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary health care. Information leaflets on this and other contraceptive methods are available on the Family Planning Association website.

How up-to-date is this topic?

How up-to-date is this topic?

Changes

Last revised in June 2012

August 2013 — minor update. Added a text to clarify that when used for the purpose of oestrogen replacement therapy the levonorgestrel-releasing IUS should be retained for no longer than 5 years after insertion (the licence states 4 years), regardless of the age of the woman at insertion.

June 2013 — minor update. The 2013 QOF options for local implementation have been added to this topic [BMA and NHS Employers, 2013].

March 2013 - minor update. The telephone number for NHS Direct has been updated.

January 2013 — minor update. Change to the text to reflect updated advice from the Faculty of Sexual and Reproductive Healthcare regarding the interaction between Esmya® and hormonal contraceptives [FSRH, 2012].

February to June 2012 — reviewed. A literature search was conducted in December 2011 to identify evidence-based guidelines, UK policy, systematic reviews, and key RCTs published since the last revision of the topic. No changes to clinical recommendations have been made. However, recommendations have been rewritten for clarity, and superseded references and manufacturers' Summary of Product Characteristics have been updated accordingly.

Previous changes

January 2012 — minor update. Typographical errors corrected. Issued in February 2012.

March 2011 — topic structure revised to ensure consistency across CKS topics — no changes to clinical recommendations have been made.

February 2010 — updated to include the revised UK medical eligibility criteria for contraceptive use, as published by the Faculty of Sexual and Reproductive Healthcare (FSRH), formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC) [FSRH, 2009c]. Issued in January 2010.

March 2009 — minor update. The Quality and Outcomes Framework (QOF) indicators for sexual health have been updated in the Goals and outcome measures section. Issued in April 2009.

September 2008 — minor correction. Typographical and table heading corrections to UK medical eligibility criteria tables on Copper intrauterine devices and Levonorgestrel-releasing intrauterine system. Issued in September 2008.

May 2008 — update to text to reflect new guidance from the Faculty of Sexual and Reproductive Healthcare (FSRH), formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC), on Intrauterine Contraception 2007. Issued June 2008.

April to September 2007 — converted from CKS guidance to CKS topic structure. The evidence-base has been reviewed in detail, and recommendations are more clearly justified and transparently linked to the supporting evidence.

July 2006 — minor update. Information regarding orlistat and reduced efficacy of oral contraceptives included in drug interactions. Issued in July 2006.

January 2006 — minor update. Gynol II Jelly, Microval tablets and Duragel have been discontinued and the prescriptions have been removed. Black triangle removed from Cerazette®. Issued in February 2006.

October 2005 — updated to include the new recommendations on missed pills from the Faculty of Family Planning and Reproductive Healthcare Clinical Effectiveness Unit, published in April 2005. Issued in November 2005.

April 2005 — minor update. Neogest® tablets have been discontinued and the prescriptions have been removed. Issued in April 2005.

February 2005 — updated to include prescribing advice from the Committee on Safety of Medicines on the effect of depot medroxyprogesterone acetate contraception on bones. Issued in February 2005.

September 2004 — updated to include the WHO Medical Eligibilty Criteria relating to contraception for 2004 and recent licence changes to Cerazette®. Delfen® Contraceptive Foam is being discontinued at the end of October 2004 and the prescriptions have been removed. Issued in September 2004.

January 2004 — reviewed. Validated in March 2004 and issued in June 2004.

January 2001 — rewritten. Validated in March 2001 and issued in June 2001. Guidance on emergency contraception is no longer included in the Contraception guidance but can be found as a separate CKS topic.

December 1997 — written.

Update

New evidence

Evidence-based guidelines

No new evidence-based guidelines since 1 December 2011.

The FSRH Clinical Effectiveness unit have published a statement on newer antiepileptic and antiretroviral drugs and interactions with hormonal contraceptives:

FSRH (2013) Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness Unit statement. March 2013. Update on newer antiepileptic and antiretroviral drugs and interactions with hormonal contraceptives. Faculty of Sexual and Reproductive Healthcare. www.fsrh.org [Free Full-text (pdf)]

HTAs (Health Technology Assessments)

No new HTAs since 1 December 2011.

Economic appraisals

No new economic appraisals relevant to England since 1 December 2011.

Systematic reviews and meta-analyses

Systematic reviews published since the last revision of this topic:

Godfrey, E.M., Folger, S.G., Jeng, G., et al. (2013) Treatment of bleeding irregularities in women with copper-containing IUDs: a systematic review. Contraception 87(5), 549-566. [Abstract]

Lan, S., Ling, L., Jianhong, Z., et al. (2013) Analysis of the levonorgestrel-releasing intrauterine system in women with endometriosis. Journal of International Medical Research 41(3), 548-558. [Abstract]

Salcedo, J., Rodriguez, M.I., Curtis, K.M., and Kapp, N. (2013) When can a woman resume or initiate contraception after taking emergency contraceptive pills? A systematic review. Contraception 87(5), 602-604. [Abstract]

Tang, J.H., Lopez, L.M., Mody, S., and Grimes, D.A. (2012) Hormonal and intrauterine methods of contraception for women aged 25 years and younger (Cochrane review). The Cochrane Library. Issue 11. John Wiley & Sons, Ltd. www.thecochranelibrary.com [Free Full-text]

Tepper, N.K., Steenland, M.W., Marchbanks, P.A. and Curtis, K.M. (2013) Hemoglobin measurement prior to initiating copper intrauterine devices: a systematic review. Contraception 87(5), 639-644. [Abstract]

Whiteman, M.K., Tyler, C.P., Folger, S.G., et al. (2013) When can a woman have an intrauterine device inserted? A systematic review. Contraception 87(5), 666-673. [Abstract]

Primary evidence

No new randomized controlled trials published in the major journals since 1 December 2011.

New policies

No new national policies or guidelines since 1 December 2011.

New safety alerts

No new safety alerts since 1 December 2011.

Changes in product availability

No changes in product availability since 1 December 2011.

Goals and outcome measures

Goals

To provide acceptable and effective contraception

QOF indicators

Table 1 . Indicators related to contraception in the Quality and Outcomes Framework (QOF) of the General Medical Services (GMS) contract.
Indicator Points Payment stages
CON001 The contractor establishes and maintains a register of women aged 54 or under who have been prescribed any method of contraception at least once in the last year, or other clinically appropriate interval e.g. last 5 years for an IUS 4 -
CON002 The percentage of women, on the register, prescribed an oral or patch contraceptive method in the preceding 12 months who have also received information from the contractor about long acting reversible methods of contraception in the preceding 12 months 3 -
CON003 The percentage of women, on the register, prescribed emergency hormonal contraception one or more times in the preceding 12 months year by the contractor practice who have received information from the contracator about long acting reversible methods of contraception at the time of or within 1 month of the prescription 3 -
Data from: [BMA and NHS Employers, 2013]

Background information

Where to get intrauterine contraception

Where can people get intrauterine contraception?

Contraception is widely available in the UK from a number of sources, and is provided free by the NHS for women and men of all ages.

Intrauterine contraception (intrauterine device and the intrauterine system) are available free of charge from:

General practices.

Contraception and sexual health clinics.

Young person's clinics.

Brook Advisory Centres (www.brook.org.uk) — for people 25 years of age and younger.

Many genito-urinary medicine clinics.

Where to get information about contraception

Where can people get information about contraception and sexual health services?

Information about contraception and sexual health services can be obtained from a number of sources including:

General practices.

The Family Planning Association (FPA). The FPA have a website and telephone helpline that provide details of all contraception and sexual health services in the UK.

Website — www.fpa.org.uk (all UK services).

Helpline England and Wales — 0845 122 8690 (9 a.m. to 6 p.m., Monday to Friday).

Helpline Northern Ireland — 0845 122 8687 (9 a.m. to 5 p.m., Monday to Thursday, and 9 a.m. to 4.30 p.m. on Friday).

For young people's clinics:

Brook centre — 0808 802 1234.

RUThinking — 0800 282 930.

3NHS Choices:

Website — www.nhs.uk

NHS Direct (England):

Telephone — 111.

Website — www.nhsdirect.nhs.uk

NHS in Northern Ireland

Website — www.n-i.nhs.uk

NHS in Scotland

NHS 24 — 08454 242424 in Scotland.

Website — www.show.scot.nhs.uk

NHS in Wales

Website — www.wales.nhs.uk

Management

Management

Scenario: Intrauterine system : covers assessing a woman's suitability for the levonorgestrel-releasing intrauterine system including: when to start using it; management of common problems (such as lost threads and unscheduled bleeding; management of uncommon problems (such as pregnancy whilst using the device and pelvic inflammatory disease); subsequent monitoring and follow up; and the advantages, disadvantages, risks, and efficacy of this method of contraception.

Scenario: Intrauterine device : covers assessing a woman's suitability for the copper intrauterine device including: when to start using it; management of common problems (such as lost threads and unscheduled bleeding); management of uncommon problems (such as pregnancy whilst using the device and pelvic inflammatory disease); subsequent monitoring and follow up; and the advantages, disadvantages, risks, and efficacy of this method of contraception.

Scenario: Intrauterine system

Scenario: Intrauterine system

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Types of IUS

What types of intrauterine system (IUS) are available?

Mirena® is the only levonorgestrel-releasing intrauterine system (IUS) licensed in the UK.

The levonorgestrel-releasing IUS is a small polyethylene T-shaped frame with a levonorgestrel reservoir around the vertical stem.

After insertion into the uterine cavity, the levonorgestrel-releasing IUS releases 20 micrograms of levonorgestrel (a progestogen) into the uterus daily.

Mirena® is effective for at least 5 years and is licensed for use for:

Contraception.

Idiopathic menorrhagia for women requiring (reversible) contraception. For more information see the CKS topic on Menorrhagia.

Protection from endometrial hyperplasia during oestrogen replacement therapy.

The licence for use of Mirena® for protection from endometrial hyperplasia is currently 4 years, as opposed to 5 years when used solely for contraception.

Mechanism of action

Mechanism of action

The contraceptive effects of the levonorgestrel-releasing intrauterine system (IUS) are mainly due to its progestogenic effect on the endometrium, which prevents implantation of the fertilized ovum. In addition, changes in cervical mucus inhibit penetration of sperm into the uterus.

More than 75% of women will continue to ovulate while using this method.

The levonorgestrel-releasing IUS has a minimal effect on the hypothalamo-pituitary-ovarian axis, and peak serum estradiol levels are greater than 100 picograms/mL in most women, which indicates that follicles are developing.

A judicial review ruled that pregnancy begins, not at fertilization, but at implantation; thus the levonorgestrel-releasing IUS is not legally considered an abortifacient.

[ABPI Medicines Compendium, 2012a]

Basis for recommendation

Basis for recommendation

This information is based on the manufacturer's Summary of Product Characteristics [ABPI Medicines Compendium, 2012a] and Judicial Review of Emergency Contraception, published by the Department of Health [DH, 2002].

Issues to discuss

What information and advice should I give a woman who is considering using the levonorgestrel–releasing intrauterine system?

Discuss:

The mechanism of action of the levonorgestrel-releasing intrauterine system (IUS).

The advantages, disadvantages, and risks of the levonorgestrel-releasing IUS.

The contraceptive efficacy of the levonorgestrel-releasing IUS.

What to do if she experiences unscheduled bleeding.

How to check for the levonorgestrel-releasing IUS and its threads, and what to do if she is unable to feel the threads.

Advise the woman:

That the levonorgestrel-releasing IUS needs to be changed every 5 years (although it can be left in for longer in certain cases).

That the levonorgestrel-releasing IUS can be removed at any time if she wishes to become pregnant and there is no delay in return to fertility.

To seek medical advice if she experiences possible features of pelvic inflammatory disease – pain or tenderness in the lower abdomen, fever, or abnormal or smelly vaginal discharge – especially within the first 3–4 weeks after insertion of the levonorgestrel-releasing IUS.

Also provide written information on the levonorgestrel-releasing IUS.

The Family Planning Association provides a useful leaflet with information for users of the levonorgestrel-releasing IUS — see www.fpa.org.uk.

Basis for recommendation

Basis for recommendation

These recommendations are based on the guideline The levonorgestrel–releasing intrauterine system in contraceptive and reproductive health issued by the Faculty of Sexual and Reproductive Healthcare [FFPRHC, 2004b] and the NICE guideline on Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005].

Starting a levonorgestrel–releasing IUS

Starting a levonorgestrel–releasing intrauterine system (IUS)

Assessment

How should I assess a woman's suitability to use the levonorgestrel-releasing intrauterine system?

In young people (aged 18 years and under) and women with special needs, assess their competence to decide, and support them in making their own decisions about contraception.

For more information on prescribing to young women and women with special needs, see the sections on Prescribing to young people and Ethical and legal issues — learning disabilities in the CKS topic on Contraception - assessment.

Exclude pregnancy . If pregnancy is possible, do not insert the levonorgestrel-releasing intrauterine system (IUS). Advise use of a barrier method (such as condoms) until pregnancy can be excluded.

If the woman does not wish to use a barrier method of contraception, consider one of the following options:

Combined hormonal contraception (pill [excluding co-cyprindiol], patch, or vaginal ring).

Progestogen-only pill.

Progestogen-only implant.

Progestogen-only injectables — if other methods are not appropriate or acceptable.

Check the UK Medical Eligibility Criteria to ensure that the woman is eligible for insertion of the levonorgestrel-releasing IUS. This will require information from the medical record, clinical history, and clinical examination, which should include bimanual pelvic examination.

Although the levonorgestrel-releasing IUS is a safe option in most women, there are a few cases where it:

Is contraindicated due to unacceptable health risks (UKMEC 4), for example in women with current breast cancer, pelvic inflammatory disease, or unexplained vaginal bleeding (before evaluation).

Should be used with caution, and after consultation with an expert (UKMEC 3), for example in women with uterine fibroids with distortion of the uterine cavity or women with a history of breast cancer and no evidence of recurrence for 5 years.

See Contraindications and cautions of the IUS for a full list of the UKMEC 3 and 4 categories.

Assess the woman's risk of sexually transmitted infections and, when appropriate, advise testing, promote safer sex, and/or refer for sexual health counselling.

If the woman is at increased risk of STIs:

Counsel her (or arrange for counselling) about safe sexual practices.

Review her decision for choice of contraception, and discuss alternative contraceptive methods or recommend correct and consistent use of condoms with the levonorgestrel-releasing IUS.

Test for Chlamydia trachomatis and, in women from areas where gonorrhoea is prevalent, test for Neisseria gonorrhoeae. If results of laboratory tests are not available, consider prophylactic antibiotics before inserting the device. For more information, see the CKS topics on Chlamydia - uncomplicated genital and Gonorrhoea.

If the woman requests testing for STIs, perform testing before inserting the device.

The following examinations and laboratory tests are not required to assess eligibility for the levonorgestrel-releasing IUS:

Breast examination, cervical screening, and routine laboratory tests including haemoglobin and blood pressure screening.

If the woman has unexplained vaginal bleeding that suggests an underlying medical condition (such as bleeding between her periods or after sexual intercourse):

Do not insert the levonorgestrel-releasing IUS until the cause of bleeding has been diagnosed.

Offer an alternative contraceptive method.

Training

Training

Intrauterine contraceptives such as the levonorgestrel-releasing intrauterine system (IUS) should only be fitted by trained personnel with continuing experience of inserting at least one device a month.

Healthcare professionals providing intrauterine or subdermal contraceptives should receive training to develop and maintain the relevant skills to provide these methods.

Studies show that clinicians fitting less than 10 devices over a 6 year period have a higher rate of perforation than clinicians fitting between 10 and 100 devices.

[FSRH, 2007]

Basis for recommendation

Basis for recommendation

These recommendations are based mainly on the UK Medical Eligibility Criteria for Contraceptive Use [FSRH, 2009c] and the guideline The levonorgestrel–releasing intrauterine system in contraceptive and reproductive health [FFPRHC, 2004b] issued by the Faculty of Sexual and Reproductive Healthcare (FSRH), formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC). They are also based on the NICE guideline on Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005].

Unable to exclude pregnancy

The Clinical Effectiveness Unit of the FSRH advise that if pregnancy cannot be excluded, combined hormonal contraception (pill [excluding co-cyprindiol], patch, vaginal ring), progestogen-only pills, and progestogen-only implants can be prescribed if [FSRH, 2010b]:

'The woman is likely to continue to be at risk of pregnancy'.

'The woman has expressed a preference to begin contraception as soon as possible'.

If pregnancy cannot be excluded, women requesting the progestogen-only injectable should be offered a suitable bridging method because the injectable cannot be removed or stopped immediately if pregnancy is diagnosed. However, if there are no other suitable methods, the progestogen-only injectable can be considered.

Methods not recommended if pregnancy cannot be excluded:

Intrauterine contraception — because of the increased risk of miscarriage.

Co-cyprindiol (Dianette®) — although it has not been shown to be harmful to human fetuses, it is not licensed for use primarily as a contraceptive.

Women at higher risk of sexually transmitted infections (STIs)

The recommendations about referring women at higher risk of STIs for counselling are based on the NICE guideline One to one interventions to reduce the transmission of sexually transmitted infections including HIV, and to reduce the rate of under 18 conceptions, especially among vulnerable and at risk groups [NICE, 2007].

Consultations on contraception should opportunistically screen (using a sexual history) for individuals at high risk of STIs.

Individuals at high risk of STIs should be offered one to one structured discussions with a practitioner trained in sexual health.

UK Medical Eligibility Criteria

UK Medical Eligibility Criteria for the levonorgestrel–releasing IUS

The UK Medical Eligibility Criteria are a set of evidence-based recommendations designed to help women select the most appropriate method of contraception for specific clinical conditions without imposing unnecessary restrictions. Each clinical condition has a recommendation for contraceptive use, categorized according to the balance of benefits and harms weighted by their probabilities for the typical user with the condition. The categories are defined in Table 1. Table 2 describes the UK Medical Eligibility Criteria for use of the levonorgestrel-releasing intrauterine system.

Table 1 . UK Medical Eligibility Criteria (UKMEC).
Category Definition
UKMEC 1 A condition for which there is no restriction for the use of the contraceptive.
UKMEC 2 A condition where the advantages of using the method generally outweigh the theoretical or proven risks.
UKMEC 3 A condition where the theoretical or proven risks usually outweigh the advantages of using the method. Provision of a method to a woman with a condition given a UKMEC Category 3 requires expert clinical judgement and/or referral to a specialist contraceptive provider since use of the method is not usually recommended unless other methods are not available or not acceptable.
UKMEC 4 A condition which represents an unacceptable health risk if the contraceptive method is used.
Source: [FSRH, 2009c]
Table 2 . UK Medical Eligibility Criteria (UKMEC) for use of the levonorgestrel-releasing intrauterine system (IUS).
Clinical feature UKMEC 1 No restrictions UKMEC 2 Advantages generally outweigh risks UKMEC 3 Requires expert clinical judgement UKMEC 4 Contraindicated
Pregnancy Pregnancy
Age >= 20 years Menarche to < 20 years
Parity Nulliparous Parous
Postpartum, breastfeeding or non-breastfeeding; and including post-Caesarean Section >= 4 weeks 48 hours to < 4 weeks Puerperal sepsis
Post-abortion First-trimester abortion Second-trimester abortion Immediately after septic abortion
Ectopic pregnancy History of ectopic pregnancy
Smoking Current or previous smoker
Obesity BMI >= 30kg/m2
Blood pressure Adequately controlled hypertension Consistently elevated blood pressure systolic >140 mmHg or diastolic >90 mmHg History of high blood pressure during pregnancy Vascular disease
Surgery History of pelvic surgery Major surgery without prolonged immobilization Minor surgery without immobilization Major surgery with prolonged immobilization
Other risk factors for venous thromboembolism (VTE) Family history of VTE in a first degree relative Varicose veins Superficial thrombophlebitis History of VTE Current VTE (on anticoagulants) Known thrombogenic mutations, for example Factor V Leiden, Prothrombin mutation, Protein S, Protein C, Antithrombin deficiencies Immobility (unrelated to surgery), for example wheelchair use, debilitating illness
Raynaud's disease Primary Secondary without lupus anticoagulant Secondary with lupus anticoagulant
Systemic lupus erythematosus SLE alone Severe thrombocytopenia Immunosuppressive treatment Positive (or unknown) antiphospholipid antibodies
Headaches Non-migrainous headaches (mild or severe) Migraine without aura (any age) Migraine with aura (any age) Past history (>= 5 years) of migraine with aura (any age)
Epilepsy Epilepsy (see drug interactions section)
Psychological conditions Depressive disorders
Breast disease Benign breast disease or a family history of breast cancer Undiagnosed mass Carriers of known gene mutations associated with breast cancer (for example BRCA1) History of breast cancer and no evidence of recurrence for 5 years Current breast cancer
Vaginal bleeding Initiation and continuation Irregular without heavy bleeding Initiation Heavy or prolonged bleeding (regular and irregular patterns) Continuation Vaginal bleeding, suspicion for serious condition Heavy or prolonged bleeding (regular and irregular patterns) Initiation Unexplained vaginal bleeding (before evaluation) suspicious for serious underlying condition
Other gynaecological conditions Initiation and continuation Benign ovarian tumours, including cysts Cervical ectropion Uterine fibroids without distortion of the uterine cavity Endometriosis Severe dysmenorrhoea Gestational trophoblastic disease when hCG is normal or decreasing Continuation Cervical cancer, awaiting treatment Endometrial cancer Ovarian cancer Initiation and continuation Other abnormalities (including cervical stenosis or cervical lacerations) not distorting the uterine cavity or interfering with IUS insertion Cervical intraepithelial neoplasia Uterine fibroids with distortion of the uterine cavity Distorted uterine cavity (any congenital or acquired uterine abnormality distorting the uterine cavity in a manner that is incompatible with IUS insertion) Initiation Ovarian cancer Initiation Cervical cancer, awaiting treatment Endometrial cancer Initiation and continuation Gestational trophoblastic disease when hCG is persistently elevated or malignant disease
Cardiovascular conditions Valvular and congenital heart disease: uncomplicated Initiation Current and history of ischaemic heart disease Stroke including TIA Initiation and continuation Multiple risk factors for arterial cardiovascular disease Valvular and congenital heart disease: complicated (for example by pulmonary hypertension, atrial fibrillation, or history of subacute bacterial endocarditis) Continuation New diagnosis of ischaemic heart disease* Stroke including TIA
Gastrointestinal conditions History of cholestasis: pregnancy related Cirrhosis, mild (compensated) Inflammatory bowel disease Gallbladder disease: asymptomatic, symptomatic treated by cholecystectomy, medically treated, or current History of cholestasis: combined oral contraceptive related Liver tumours: benign (focal nodular hyperplasia) Cirrhosis, severe (decompensated) Liver tumours: benign (hepatocellular adenoma) Liver tumours: malignant (hepatoma)
Infections For initiation and continuation Past pelvic inflammatory disease (assuming no current risk factors for STIs) Schistosomiasis Non-pelvic tuberculosis Malaria Viral hepatitis: acute or flare, carrier or chronic For initiation and continuation Other STIs (excluding HIV and hepatitis) Vaginitis Increased risk of STIs High risk of HIV HIV, not using antiretroviral therapy HIV, using antiretroviral therapy‡ AIDS For continuation Current pelvic inflammatory disease Chlamydia (symptomatic or asymptomatic) Current purulent cervicitis or gonorrhoea For initiation HIV, using antiretroviral therapy‡ For continuation Known pelvic tuberculosis For initiation Current pelvic inflammatory disease Chlamydia (symptomatic or asymptomatic) Current purulent cervicitis or gonorrhoea Known pelvic tuberculosis
Diabetes mellitus History of gestational diabetes NIDDM and IDDM, non-vascular disease With nephropathy, retinopathy, neuropathy; or other vascular disease
Thyroid Simple goitre, hypothyroid, hyperthyroid
Haematological conditions Anaemias: thalassaemia, iron deficiency, sickle cell disease
Dyslipidaemia Known hyperlipidaemias
Antiretroviral therapy drug interactions (and consistent use of condoms is recommended) For initiation and continuation Nucleoside reverse transcriptase inhibitors Non-nucleoside reverse transcriptase inhibitors Ritonavir-boosted protease inhibitors For initiation Nucleoside reverse transcriptase inhibitors Non-nucleoside reverse transcriptase inhibitors Ritonavir-boosted protease inhibitors
Anticonvulsant therapy drug interactions Certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine) Lamotrigine
Antimicrobial therapy drug interactions Broad spectrum antibiotics Antifungals Antiparasitics Rifampicin or rifabutin therapy
BMI = body mass index; CIN = cervical intraepithelial neoplasia; hCG = human chorionic gonadotrophin; IDDM = insulin-dependent diabetes; IUD = intrauterine device; NIDDM = non-insulin-dependent diabetes; STI = sexually transmitted infection; SLE = Systemic lupus erythematosus; TIA = transient ischaemic attack; VTE = venous thromboembolism. * Clinical judgement and assessment of pregnancy risk and other factors is required to determine whether the levonorgestrel-releasing IUS can be continued. † The consistent use of condoms is recommended for women with HIV or AIDs on antiretroviral therapy, to prevent HIV transmission. ‡ HIV, using antiretroviral therapy is classified as Category 3 for initiation and Category 2 for continuation unless the woman is clinically well on antiretroviral therapy, in which case both initiation and continuation are classified as Category 2.
Data from: [FSRH, 2009c]

Contraindications and cautions of the IUS

Contraindications and cautions of the intrauterine system

Women should not use the levonorgestrel-releasing IUS (UKMEC 4) in the following situations:

Pregnancy

Postpartum: puerperal sepsis

Post abortion: septic abortion

Current breast cancer

Unexplained vaginal bleeding: before evaluation

Gestational trophoblastic disease when the human chorionic gonadotropin level is persistently elevated or in malignant disease

Cervical cancer: awaiting treatment when considering inserting the IUS. However, if the woman already has an IUS fitted it can be left in situ (UKMEC 2).

Endometrial cancer when considering inserting the IUS. However, if the woman already has an IUS fitted it can be left in situ (UKMEC 2).

Pelvic inflammatory disease: current when considering inserting the IUS. However, if the woman already has an IUS fitted it can be left in situ (UKMEC 2).

Sexually transmitted infections: current purulent cervicitis, or gonorrhoea, symptomatic or asymptomatic chlamydial infection when considering inserting the IUS. However, if the woman already has an IUS fitted it can be left in situ (UKMEC 2).

Known pelvic tuberculosis when considering inserting the IUS. If the woman already has an IUS fitted it may need to be removed (UKMEC 3) — seek specialist advice.

Women should use the levonorgestrel-releasing IUS only after consultation with an expert (UKMEC 3) in the following situations:

Postpartum: 48 hours to less than 4 weeks — delay inserting the IUS at least 4 weeks after childbirth. Barrier method (such as condoms) should be advised until then.

New diagnosis of ischaemic heart disease while fitted with the IUS. Clinical judgement and assessment of pregnancy risk and other factors is required to determine whether the IUS can be continued.

Stroke or transient ischaemic attack while fitted with the IUS

Past history of breast cancer with no recurrence in the last 5 years

Uterine fibroids with distortion of the uterine cavity

Distorted uterine cavity (any congenital or acquired uterine abnormality distorting the uterine cavity in a manner that is incompatible with IUS insertion)

Pelvic tuberculosis: known while fitted with the IUS

Cirrhosis: severe (decompensated)

Liver tumours: benign (hepatocellular adenoma) and malignant (hepatoma)

Systemic lupus erythematosus: positive (or unknown) antiphospholipid antibodies

HIV infected: using antiretroviral therapy (see Scenario: Concurrent medication)

Classified as UKMEC 3 for initiation and UKMEC 2 for continuation unless the woman is clinically well on antiretroviral therapy, in which case both initiation and continuation are classified as UKMEC 2.

Ovarian cancer when considering inserting the IUS. However, if the woman already has an IUS fitted it can be left in situ (UKMEC 2)

Immobility unrelated to surgery (for example wheelchair use, debilitating illness)

Basis for recommendation

Basis for recommendation

These recommendations are based on the UK Medical Eligibility Criteria for Contraceptive Use issued by the Faculty of Sexual and Reproductive Healthcare [FSRH, 2009c].

When to insert — first use or switching

When can the levonorgestrel-releasing intrauterine system be inserted?

First use

If possible, insert the levonorgestrel-releasing intrauterine system (IUS) within 7 days of the onset of menstruation. No additional contraception is required.

If this is not possible, insert the IUS at any time in the menstrual cycle provided it is reasonably certain that the women is not pregnant.

Advise the woman to avoid sexual intercourse or use a barrier method of contraception (such as condoms) for 7 days after insertion of the IUS.

If there is a delay before the IUS can be fitted:

Use a bridging method or advise the woman to use a barrier method of contraception (for example condoms) in the interim, and reschedule the fitting to a mutually convenient time.

Combined hormonal contraception (pill, patch, or vaginal ring [not suitable post-partum if the woman is breastfeeding]), the progestogen-only pill, or the progestogen-only injectable can be used as a bridging method.

For more information, see the CKS topics on Contraception - combined hormonal methods and Contraception - progestogen-only methods.

Replacing an existing IUS with a new IUS

Replace the existing IUS with the new IUS at any time in the menstrual cycle. No additional contraceptive protection is required after insertion if the new IUS is inserted immediately after removing the existing IUS.

Advise the woman to avoid intercourse or use barrier contraception for the 7 days before the replacement, in case the reinsertion fails.

Replacing an IUS with a copper intrauterine device (IUD)

Replace the IUS with the copper IUD at any time in the menstrual cycle. No additional contraceptive protection is required after insertion if the IUD is inserted immediately after removing the levonorgestrel-releasing IUS.

Advise the woman to avoid sexual intercourse or use a barrier method of contraception (such as condoms) for the 7 days before the procedure, in case reinsertion fails.

Switching from another contraceptive method

Insert the IUS at any time in the menstrual cycle provided that the other method of contraception has been used consistently and correctly, and it is reasonably certain that the woman is not pregnant.

There is no need to wait for the next menstrual period or withdrawal bleed.

Advise a barrier method of contraception (such as condoms) for 7 days after insertion unless the current contraceptive method is still effective, for example:

Less than 12 weeks since last progestogen-only injection.

Within 3 years of insertion of a progestogen-only implant.

No later than day 1 of the hormone-free interval for pills or patch.

Postpartum (including post-Caesarean section and breastfeeding)

If possible, delay insertion of the IUS until 6 weeks postpartum (licensed use). Otherwise, consider inserting the IUS after 4 weeks postpartum (off–label use).

Advise women who are not fully breastfeeding to use another method of contraception from 21 days postpartum until insertion of the IUS.

After abortion

Following surgical abortion:

Insert the IUS at the time of a first or second trimester surgical abortion for immediate contraceptive cover.

Following medical or surgical abortion:

The IUD can be inserted by an experienced clinician, anytime following medical or a third trimester surgical abortion, as long as there is no suspicion that the woman is still pregnant.

Otherwise, insertion should be done within the first 48 hours postpartum or delayed until 4 weeks postpartum.

Excluding pregnancy

How can I be reasonably certain that a woman is not pregnant?

A woman is unlikely to be pregnant if she has no signs or symptoms of pregnancy and meets at least one of the following criteria. She:

Has not had intercourse since the start of the last normal period.

Has been correctly and consistently using a reliable method of contraception.

Some experts would not regard condoms or natural family planning as reliable enough to exclude the possibility of pregnancy.

Is within 7 days after the start of a normal period.

Is within 7 days after abortion or miscarriage.

Is fully or nearly fully breastfeeding, amenorrhoeic, and less than 6 months postpartum.

Is not breastfeeding and less than 3 weeks postpartum, or has had no unprotected sex since delivery.

These criteria are helpful in ruling out pregnancy in most clinical circumstances. However, other means must be used to exclude pregnancy when these criteria do not apply, such as in women who are 4 weeks or more postpartum and not breastfeeding, or in women who are amenorrhoeic and not less than 6 months postpartum.

A pregnancy test can support the assessment, but only if 3 weeks have elapsed since the date of last intercourse.

Basis for recommendation

Basis for recommendation

These recommendations are based mainly on the guidelines The levonorgestrel–releasing intrauterine system in contraceptive and reproductive health and Intrauterine contraception issued by the Faculty of Sexual and Reproductive Healthcare (FSRH), formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC) [FFPRHC, 2004b; FSRH, 2007], and the NICE guideline on Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005].

Insertion of the levonorgestrel-releasing intrauterine system (IUS)

The manufacturers recommend that the levonorgestrel-releasing IUS is inserted within 7 days of the onset of menstruation [ABPI Medicines Compendium, 2012a]. However, the Clinical Effectiveness Unit at the FSRH advise that it can be inserted at any time in the cycle provided there is no risk of pregnancy [FSRH, 2007].

Additional contraceptive cover for 7 days following insertion of the IUS

The levonorgestrel–releasing IUS takes 7 days to provide effective contraceptive protection so unless it is inserted within the first 7 days of the onset of menses, additional contraception should be used for the 7 days following the insertion [FSRH, 2007].

Bridging methods

The advice on suitable bridging methods if there is a delay before an IUS can be fitted is taken from the Quick starting contraception guideline issued by the FSRH [FSRH, 2010b]. It states that:

'If a woman’s method of choice cannot be started immediately, a short-acting method such as the combined hormonal contraception (pill, patch, or vaginal ring) or the progestogen-only pill can be started as a bridging method until pregnancy has been excluded and the preferred method initiated' [FSRH, 2010b].

CKS recognizes that a bridging method may not always be possible, therefore, a barrier method can also be considered, and may be more acceptable to the woman, if there is a delay before an IUS can be fitted.

Additional contraceptive cover for 7 days before insertion of the IUS

The most likely time for becoming pregnant (fertile period) is from about 7 days before ovulation until about 2 days after ovulation, and sperm in a woman's reproductive tract can remain viable for up to 7 days [FPA, 2010]. If unprotected sexual intercourse occurs in the fertile period and reinsertion fails, the woman may become pregnant.

Inserting the IUS postpartum

This recommendation is based on the manufacturer's Summary of Product Characteristics [ABPI Medicines Compendium, 2012a].

Some experts suggest that insertion of the IUS can be considered within 48 hours of delivery, however, the FSRH advises that there may be an increased risk of uterine perforation if the IUS is inserted between 48 hours and 4 weeks postpartum [FFPRHC, 2004a; FSRH, 2007].

Insertion of an IUS before 4 weeks postpartum has a UKMEC category of 3 which means that the risks generally outweigh the benefits [FSRH, 2009a].

The recommendation that women who are not fully breastfeeding should use another method of contraception from 21 days postpartum until insertion is based on the guideline Postnatal Sexual and Reproductive Health produced by the FSRH [FSRH, 2009a].

Before Day 21 postpartum no contraceptive methods are required for both breastfeeding and non-breastfeeding women.

In women who are not breastfeeding, ovulation may occur as early as Day 28 and since the sperm can survive for up to 7 days in the female genital tract, contraceptive protection is needed from Day 21 postpartum in order to avoid unwanted pregnancy.

Women who are fully breastfeeding may wish to rely on the lactational amenorrhoea method (LAM) alone until breastfeeding reduces or other LAM criteria are no longer fulfilled. For more information on the LAM, see the CKS topic on Contraception - natural family planning.

Inserting the IUS after an abortion

In the past the recommendation for IUS insertion following a medical or surgical abortion, was to insert the IUS within the first 48 hours or delay until 4 or more weeks postpartum. However, the the Clinical Effectiveness Unit (CEU) at the FSRH now recommend that after counselling and if the IUS is preferred, it can be inserted by an experienced clinician anytime after abortion. This is because waiting until 4 or more weeks postpartum may put some women at risk of unwanted pregnancy [FSRH, 2007].

There is no evidence that there is an increased risk of uterine perforation if the IUS is inserted in the weeks following an abortion [FSRH, 2007].

The manufacturers state that the IUS can be inserted immediately after the first trimester abortion [ABPI Medicines Compendium, 2012a].

Follow-up

What follow up is recommended following insertion of the levonorgestrel-releasing intrauterine system (IUS)?

Follow up the woman after the first menses, or 3–6 weeks after insertion, to exclude infection, perforation, or expulsion.

Consider the possibility of uterine perforation if a woman returns within the first few days of insertion complaining of marked pain (which may only be intermittent), and the threads cannot be located.

If uterine perforation is suspected, arrange an urgent ultrasound scan and/or abdominal X-ray to locate the device.

Advise the woman to return at any time if she:

Is unable to feel the threads of her levonorgestrel-releasing intrauterine system (IUS).

Wants to change the method of contraception, or her IUS is due to be changed (after 5 years).

Has missed her period, or has other reasons to think that she might be pregnant.

Has unscheduled bleeding or an unexpected change in pattern of bleeding — further investigations will be needed to exclude infection, pregnancy, and gynaecological pathology.

Basis for recommendation

Basis for recommendation

These recommendations are based on the guidelines The levonorgestrel–releasing intrauterine system in contraceptive and reproductive health issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC) [FFPRHC, 2004b], and the NICE guideline on Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005].

Duration of use

How long can the levonorgestrel-releasing intrauterine system be left in place?

The levonorgestrel-releasing intrauterine system (IUS) can be left in place for up to 5 years (when used for contraception).

Duration when approaching menopause

Continue the IUS until the woman is 50 years of age and:

If she is amenorrhoeic, consider one of the following options:

Continue the IUS and and check follicle stimulating hormone (FSH) levels on two occasions, with an interval of 6 weeks between tests. If both FSH levels are more than 30 IU/L, stop contraception after 1 more year.

Continue the IUS till age 55 years (when natural loss of fertility can be assumed for most women) and stop.

If the woman is not amenorrhoeic at age 55 years:

Continue the IUS beyond 55 years of age until the woman has been amenorrhoeic for 1 year. However, consider investigating any abnormal bleeding or changes in bleeding pattern.

Women who have the IUS fitted solely for the purpose of contraception at age 45 years or more can:

If amenorrhoeic, retain the device until the menopause (even if this is beyond the duration of the UK Marketing Authorisation [off–label use]) after which the device should be removed.

If not amenorrhoeic, use the IUS for 7 years (instead of the licensed 5 years) if their bleeding pattern is acceptable (off-label use).

Women who had the IUS fitted solely for heavy menstrual bleeding at age 45 years or more can continue with the IUS until the menopause.

For more information, see the CKS topic on Menorrhagia.

Basis for recommendation

Basis for recommendation

Stopping contraception around menopause

The Clinical Effectiveness Unit at the Faculty of Sexual and Reproductive Health Care advise that contraception may be stopped at the age of 55 years. However, they highlight that the advice may need to be tailored to the individual woman [FSRH, 2010a].

The FSRH advises that women 50 years and over can use the levonorgestrel-releasing intrauterine system (IUS) until the age of 55 years or until the menopause can be confirmed.

Diagnosing the menopause [FSRH, 2010a]

The menopause is usually diagnosed clinically and retrospectively after 1 year of amenorrhoea.

Although raised serum follicle stimulating hormone (FSH) level indicate a degree of ovarian failure (FSH level of more than 30 IU/L is highly suggestive of ovarian failure), it is not predictive of when menopause has occurred. Other factors such as age of the woman, and her menstrual cycle and bleeding patterns may be the most useful factors in determining the likelihood of the approaching menopause, unless menstrual bleeding patterns are altered by the use of hormonal contraception.

FSH levels may be helpful in diagnosing the menopause but should only be reserved for women who are over the age of 50 years (as they are more likely to be menopausal) and using the progestogen-only methods of contraception (FSH levels are not a reliable indicator of ovarian failure in women using the combined hormonal contraception, even if measured during the hormone-free interval).

Rechecking FSH levels after 6 weeks

This recommendation is based on the guidance Contraception for women aged over 40 years issued by the FSRH [FSRH, 2010a].

The progestogen-only pills guidance (also issued by the FSRH) recommends that the FSH levels are checked 1-2 months apart [FSRH, 2009b].

IUS inserted at 45 years or over solely for contraception

More than 75% of women fitted with the IUS will continue to ovulate. However, amenorrhoea or light bleeding is common after the first 12 months of use [FSRH, 2010a].

The FSRH advises that if a woman has the IUS fitted solely for contraception at 45 years of age or over, they can continue to use it for 7 years, instead of the licensed 5 years, providing their bleeding pattern is acceptable [FSRH, 2010a].

The National Institute for Health and Care Excellence advises that women who have an IUD fitted at 45 years of age or over, and are amenorrhoeic, can retain it until they are postmenopausal [NICE, 2005].

IUS removal or replacement

When can the levonorgestrel-releasing intrauterine system (IUS) be safely removed or replaced?

If the woman wishes to become pregnant, remove the device at any time in the menstrual cycle.

If the woman does not wish to become pregnant, remove the device in the first few days after the onset of menstruation, or at any other time provided that there has been no unprotected sexual intercourse in the preceding 7 days.

If switching from the IUS to any other method of contraception, see the CKS topic for that method for more information.

Basis for recommendation

Basis for recommendation

These recommendations are based mainly on the guidelines The levonorgestrel–releasing intrauterine system in contraceptive and reproductive health and Intrauterine contraception issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC) [FFPRHC, 2004b; FSRH, 2007], and the NICE guideline on Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005].

Unable to feel the threads ('lost threads')

What should I do if the woman cannot feel the threads of her levonorgestrel-releasing intrauterine system?

Do not assume expulsion.

Advise a barrier method of contraception (for example condoms) or abstinence until it is confirmed that the IUS is intrauterine (or not).

Consider the need for emergency contraception if sexual intercourse occurred in the 7 days prior to 'lost threads'. See the CKS topic on Contraception - emergency for more information.

Perform a vaginal examination.

If no threads are visible on speculum examination and uterine placement of the IUS cannot be confirmed clinically, refer the woman immediately for an urgent ultrasound scan to locate the device (advise a barrier method of contraception [for example condoms] or abstinence until the scan).

Experienced clinicians may use a thread retriever, Spencer Wells forceps, or uterine sonography to identify and retrieve the threads.

If ultrasonography cannot locate the device and there is no definite evidence of expulsion, arrange for an abdominal X-ray.

Advise a barrier method of contraception (for example condoms) or abstinence until the procedure.

If the device is extrauterine, or if partial perforation or embedment into the uterine wall is suspected, refer for surgical retrieval.

Advise a barrier method of contraception (for example condoms) or abstinence until the procedure.

Arrange for the woman to resume regular contraception after the procedure.

If the device is proven to be intrauterine, consider retaining the device or replacing it with a new IUS.

If replacement is considered, discuss the risks of changing the device (such as infection, expulsion, and perforation).

Basis for recommendation

Basis for recommendation

These recommendations are based on the guidelines The levonorgestrel–releasing intrauterine system in contraceptive and reproductive health and Intrauterine contraception issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC) [FFPRHC, 2004b; FSRH, 2007].

Unscheduled bleeding

How should I manage abnormal vaginal bleeding in a woman using the levonorgestrel-releasing intrauterine system (IUS)?

Abnormal bleeding is a particular problem with the levonorgestrel-releasing intrauterine system (IUS).

Irregular, light, or heavy bleeding is common in the first 6 months of use, and about 65% of women have amenorrhoea or reduced bleeding at 1 year.

Exclude or manage other situations which could result in unscheduled bleeding, such as:

Sexually transmitted infections (STIs).

The risk of STIs is increased if the woman is under 25 years, has a new sexual partner, or has had more than one sexual partner in the last year.

Misplaced device.

Pregnancy.

Gynaecological conditions such as endometrial polyps, endometrial cancer, cervical cancer, or other gynaecological abnormality.

Speculum examination is warranted:

For persistent bleeding beyond the first 3–6 months of use.

For new symptoms or a change in bleeding after at least 3 months of use.

If the woman has not participated in a National Cervical Screening programme.

If requested by the woman.

If there are other symptoms such as pain, dyspareunia, or post coital bleeding. (Note that these symptoms also warrant pelvic examination.)

If the above causes of menstrual irregularities have been excluded, and the results of the speculum examination are clear, the irregularity can be assumed to be caused by the IUS. Providing the woman has no other symptoms:

Reassure the woman that irregular bleeding is normal, and is not due to the hormone 'running out'.

40% of the levonorgestrel load is still present in the IUS after 5 years of use.

Consider managing heavy unscheduled bleeding by treating with a combined oral contraceptive (30-35 micrograms of ethinylestradiol with levonorgestrel or norethisterone) either cyclically or continuously for up to 3 months (unlicensed use).

Refer if the cause of the bleeding cannot be determined or treated in primary care.

Basis for recommendation

Basis for recommendation

These recommendations are based mainly on the guidelines Long–acting reversible contraception published by the National Institute for Health and Care Excellence [National Collaborating Centre for Women's and Children's Health, 2005], Management of unscheduled bleeding in women using hormonal contraception [FSRH and RCOG, 2009] issued by the Faculty of Sexual and Reproductive Healthcare (FSRH), formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC), and the NHS Clinical Practice Guidance for the Assessment of young women aged 20–24 with abnormal vaginal bleeding [DH, 2010].

After 5 years of use, 40% of the levonorgestrel load is still present in the levonorgestrel-releasing intrauterine system [Luukkainen et al, 1986]. It is therefore unlikely that any change in bleeding pattern is a result of hormone 'running out', and other causes of the bleeding must be sought.

Pregnant whilst using IUS

How should I manage a woman who becomes pregnant whilst using a levonorgestrel-releasing intrauterine system (IUS)?

If a woman is found to be pregnant whilst using the levonorgestrel-releasing intrauterine system (IUS):

Exclude the possibility of an ectopic pregnancy.

Inform her that:

The risks of second-trimester miscarriage, preterm delivery, and infection are increased if the device is left in situ.

The device should be removed within the first 12 weeks of gestation.

If the woman wishes to continue with the pregnancy:

Inform her that removal, where possible, would reduce adverse effects. However, removal itself carries a small risk of miscarriage.

Remove the device, provided that the woman understands the risks and agrees to removal.

Whether or not the device is removed, a pregnant woman should be advised to seek medical care if she develops heavy bleeding, cramping pain, abnormal vaginal discharge, or fever.

Basis for recommendation

Basis for recommendation

These recommendations are based on the guidelines The levonorgestrel–releasing intrauterine system in contraceptive and reproductive health and Intrauterine contraception issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC) [FFPRHC, 2004b; FSRH, 2007].

Managing pelvic inflammatory disease

How should I manage pelvic inflammatory disease in a woman using a levonorgestrel-releasing intrauterine system (IUS)?

If pelvic inflammatory disease (PID) is diagnosed in a woman using the levonorgestrel-releasing intrauterine system (IUS):

Test for the causative organism and start appropriate antibiotic treatment. For information on testing and antibiotics, see the CKS topic on Pelvic inflammatory disease.

Consider removing the IUS if the woman wishes removal, or if symptoms have not resolved within 72 hours.

If a decision is made to remove the device and the woman has had sexual intercourse within the last 7 days, consider offering emergency hormonal contraception. For more information see the CKS topic on Contraception - emergency.

If the woman develops pelvic pain and has had actinomyces-like organisms (ALOs) identified on a smear in the past:

Take endocervical swabs and urgently seek specialist advice regarding treatment.

Consider removal of the IUS.

Follow up all women with confirmed or suspected PID to ensure:

Resolution of symptoms and signs.

Completion of the course of antibiotics.

Risk assessment for sexually transmitted infections.

Counselling regarding safer sex.

Partner notification and treatment.

Basis for recommendation

Basis for recommendation

These recommendations are based mainly on the guidelines The levonorgestrel–releasing intrauterine system in contraceptive and reproductive health and Intrauterine contraception issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC) [FFPRHC, 2004b; FSRH, 2007].

Evidence is limited and expert opinion is divided over whether it is necessary to remove the device at the initial presentation. However, experts agree that the device should be removed if the woman wishes removal or if symptoms have not resolved within 72 hours.

Actinomyces-like organisms on a cervical smear

How should I manage a woman who has actinomyces-like organisms on a cervical smear and is using a levonorgestrel-releasing intrauterine device (IUS)?

If a woman who is using the levonorgestrel-releasing intrauterine system (IUS) has actinomyces-like organisms (ALOs) seen on a cervical smear:

Assess her for signs and symptoms of pelvic inflammatory disease such as:

Lower abdominal pain and tenderness (usually the most prominent symptom).

Dyspareunia.

Abnormal vaginal bleeding (for example menorrhagia, postcoital, or intermenstrual bleeding).

Abnormal vaginal discharge.

Dysuria (pelvic inflammatory disease can occur with concurrent urethral chlamydial infection).

Nausea and vomiting (rare other than in acute infection).

If the woman is asymptomatic:

Advise her that it is not necessary to remove the device unless signs or symptoms of infection occur.

If the woman has symptoms of pelvic inflammatory disease, see the CKS topic on Pelvic inflammatory disease.

Basis for recommendation

Basis for recommendation

These recommendations are based mainly on the guidelines The levonorgestrel–releasing intrauterine system in contraceptive and reproductive health and Intrauterine contraception issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC) [FFPRHC, 2004b; FSRH, 2007].

Advantages, disadvantages, and risks

What are the advantages, disadvantages, and risks of the levonorgestrel-releasing intrauterine system?

Advantages

Very safe.

Very effective.

A single decision leads to effective long-term prevention of pregnancy (5 years). There is little for the user to remember once the device is inserted.

Sex need not be interrupted to use contraception.

Periods usually become lighter and shorter, and sometimes less painful. They may stop completely after the first year of use. Therefore, the levonorgestrel intrauterine system (IUS) can be useful for women with heavy, painful periods.

Immediately reversible; normal fertility returns as soon as the device is removed.

Can be used in women of any age, whether or not they have previously been pregnant.

Can be inserted from 4 weeks after delivery (off-label use), irrespective of mode of delivery or immediately after first or second trimester abortion (by an experienced clinician).

Can be used with breastfeeding.

Can be used through the menopause.

There are no known interactions with any medicines.

Can be used when combined oral contraceptives (COCs) are contraindicated, for example in women who have migraine or venous thromboembolism (women with current venous thromboembolism who need hormonal contraception during anticoagulant treatment should be referred to a specialist in contraceptive care).

Disadvantages

An internal pelvic examination is needed to check that the levonorgestrel-releasing IUS is suitable, and to insert the device.

There may be pain or discomfort for a few hours after insertion; this can be treated with an analgesic such as paracetamol or ibuprofen.

The woman cannot discontinue use on her own. A trained healthcare provider must remove the device.

It does not protect against sexually transmitted infections (STIs), including HIV. However, the risk of HIV is not increased.

The IUS can be expelled without the woman knowing (although this is uncommon, less than 1 in 20 women in 5 years). It is important therefore that she checks for the presence of threads regularly (for example after every menstrual period). Some women may not want to do this internal examination.

Menstrual changes are common in the first 6 months. Periods may become lighter than usual or may continue to be irregular, and many women find that their periods stop altogether by the end of the first year of use. Some women consider this an advantage.

Up to 60% of women stop using the levonorgestrel-releasing IUS within 5 years. The most common reasons for discontinuation are unacceptable vaginal bleeding and pain. A less common reason is hormonal (non-bleeding) problems.

Other adverse effects may include acne and headaches. Some women report that their breasts become more tender.

Some women develop functional ovarian cysts; this does not usually need to be treated as the cysts tend to resolve spontaneously. Often, there are no symptoms, but some women may experience pelvic pain.

Risks

Perforation of the wall of the uterus — rare; this happens in less than 1 in 1000 women and is dependent on the skills of the clinician.

Pelvic inflammatory disease follows insertion rarely (less than 1 in 100 women who are at low risk of STIs).

Ectopic pregnancy. Pregnancy with the device in place is rare (about 1 in 1000 in 5 years), but when it does occur, the risk of it being ectopic is about 1 in 20.

Basis for recommendation

Basis for recommendation

These recommendations are based on the guidelines The levonorgestrel–releasing intrauterine system in contraceptive and reproductive health issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC) [FFPRHC, 2004b], and the National Institute for Health and Care Excellence (NICE) guideline on Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005].

Drug interactions

Drug interactions

Drugs that compete for progesterone receptors

Ulipristal acetate — this has recently been licensed for the pre-operative treatment of moderate to severe symptoms of uterine fibroids (Esmya®). The dose used for this new indication is lower (5 mg daily) than that used for emergency contraception (30 mg as a one-off dose). The manufacturers of Esmya® advise avoiding concomitant use of a progestogen releasing intrauterine device.

Basis for recommendation

Basis for recommendation

The manufacturers of the two ulipristal acetate preparations available in the UK (Esmya® ellaOne®), give different advice regarding drug interactions with hormonal contraceptives [ABPI Medicines Compendium, 2012c; ABPI Medicines Compendium, 2012d]. The FSRH are aware of this and have written to the European Medicines Agency for clarification regarding this matter [FSRH, 2012]. Until further information is available, the FSRH advise that women who are taking Esmya® for uterine fibroids should follow the manufacturers' current advice. The manufacturers advise that concomitant use of progestogen-only pills, a progestogen-releasing intrauterine device, or combined oral contraceptive pills is not recommended [ABPI Medicines Compendium, 2012c].

Efficacy

How effective is the levonorgestrel–releasing intrauterine system at preventing pregnancy?

For comparison of the efficacy of the levonorgestrel–releasing intrauterine system (IUS) with other methods, see Comparative efficacy.

When inserted correctly, 0.1% (1 out of 1000 women) will conceive within the first year of use due to method failure.

Comparative efficacy

Efficacy of different contraceptive methods

Table 1 . Summary of the efficacy of different contraceptive methods available in the UK, and their continuation rates (based on studies in the US)
Method Percentage of women experiencing an unintended pregnancy within the first year of use Percentage using the method 1 year after starting it
Typical use* Perfect use†
No method 85% 85%
Natural family planning 25% 1–9% depending on method 51%
Tablets (combined oral contraceptives and progestogen-only pill) 8% 0.3% 68%
Injectable medroxyprogesterone (Depo-Provera®) 3% 0.3% 56%
Etonogestrel implant 0.05% 0.05% 75%
Combination contraceptive patch 8% 0.3% 68%
Combined contraceptive vaginal ring 0.96 Pearl Index 0.64 Pearl Index
Copper intrauterine device (IUD): ParaGard (TCu 380A) 0.8% 2% cumulative pregnancy rate over 12 years 0.6% 2% cumulative pregnancy rate over 12 years 78%
Levonorgestrel-releasing intrauterine system (IUS) 0.1% 0.1% 81%
Diaphragm plus spermicide 16% 6% 57%
Cervical cap plus spermicide: Parous women Nulliparous women 32% 16% 20% 9% 46% 57%
Female condom (without spermicide) 21% 5% 49%
Male condom (without spermicide) 15% 2% 53%
Withdrawal 27% 4% 43%
Female sterilization 0.5% 1 in 200 lifetime-failure rate 0.5% 1 in 200 lifetime-failure rate 100%
Male sterilization 0.15% 1 in 700 lifetime-failure rate 0.05%§ 1 in 2000 lifetime-failure rate§ 100%
* The percentage of typical couples who start this method of contraception (not necessarily for the first time) and experience an accidental pregnancy during the first year (due to method failure, user failure, or provider failure), provided they do not stop for any other reason. † The percentage of couples who start this method of contraception (not necessarily for the first time) and who use it perfectly (both consistently and correctly) and experience an accidental pregnancy during the first year (due to method failure), provided they do not stop for any other reason. ‡ Pearl Indices (number of pregnancies per 100 woman years of use) found in clinical studies with Nuvaring® shows that the combined vaginal ring has a comparable efficacy with that known for combined oral contraceptives [ABPI Medicines Compendium, 2012b]. A Cochrane review comparing the combined contraceptive pill, patch, and vaginal ring also showed that all three methods have similar efficacy (0.3% when used perfectly and 8% when used typically) [Lopez et al, 2010]. § These figures are from the guideline Male and female sterilisation published by the Royal College of Obstetricians and Gynaecologists [RCOG, 2004] and information published by the Family Planning Association [FPA, 2011], and differ from the figures quoted in the reference below (1 in 1000 lifetime-failure rate, 0.10%) [National Collaborating Centre for Women's and Children's Health, 2005].
Data on failure rates are adapted from table 3.2 in [National Collaborating Centre for Women's and Children's Health, 2005], which adapted data from [Trussell, 2004]. Data on continuation rates are from the text of [National Collaborating Centre for Women's and Children's Health, 2005].

Basis for recommendation

Basis for recommendation

These recommendations are based on the National Institute for Health and Care Excellence (NICE) guideline on Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005].

Scenario: Intrauterine device

Scenario: Copper-containing intrauterine device

156months720monthsFemale

Preferred types of IUD

What types of intrauterine device (IUD) are preferred?

The preferred copper intrauterine devices (IUDs) contain 380 mm2 of copper, have banded copper on the arms, and are licensed for longer duration of use.

Framed IUDs with 380mm2 copper (stem and arms)

TT 380® Slimline — duration of use: 10 years

T–Safe® 380A QL — duration of use: 5 years

FlexiT® + 380 — duration of use: 5 years

Framed IUDs with 380mm2 copper (Stem only)

UT 380 Short® — duration of use: 10 years

UT 380 Standard® — duration of use: 10 years

Neo–Safe® T380 — duration of use: 5 years

Nova–T® 380 — duration of use: 5 years

Framed IUDs with less than 380mm2 copper

FlexiT® 300

Load® 375

Multiload® Cu375

Multi–Safe® Cu375

Frameless IUDs

GyneFix® (contains 300mm2 copper)

Mechanism of action

Mechanism of action

The primary mode of action of copper intrauterine devices (IUDs) is via the toxic effects of copper on the ovum and sperm, preventing fertilization.

In addition, alterations in the copper content of cervical mucus may inhibit penetration by sperm, and inflammatory reactions within the endometrium may prevent implantation, should the ovum be fertilized [Stanford and Mikolajczyk, 2002; FFPRHC, 2004a]. Consequently, the copper IUD can work immediately after insertion.

A judicial review ruled that pregnancy begins, not at fertilization, but at implantation; thus the copper IUD is not legally considered an abortifacient [DH, 2002].

Basis for recommendation

Basis for recommendation

This recommendation is based on the National Institute for Health and Care Excellence (NICE) guidance Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005]. In particular:

The recommendation to use framed copper intrauterine devices (IUDs) with 380 mm2 copper is based on results from randomized controlled trials:

Women using the Multiload Cu375 had a higher cumulative pregnancy rate (5.3%) compared with women using TCu 380A (3.4%) for up to 10 years.

Women using Nova-T 380 had a cumulative pregnancy rate of under 2% for up to 5 years.

There was no significant difference in cumulative pregnancy rates between the frameless devices (0% to 2%) and the framed device (TCu 380A, 0.3% to 1.6%) after 3 years of use.

The recommendation from NICE to prefer IUDs with 380 mm2 copper supersedes that issued in an earlier guideline published by the Faculty of Sexual and Reproductive Healthcare (FSRH), formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC), which recommended at least 300 mm2 copper [FFPRHC, 2004a].

The advice to use a copper IUD with the longest licensed duration of use is intended to minimize the risks associated with reinsertion of replacements [FFPRHC, 2004a; National Collaborating Centre for Women's and Children's Health, 2005].

Issues to discuss

What information and advice should I discuss with a woman who is considering using an intrauterine device?

Discuss:

The mechanism of action of the copper intrauterine device (IUD).

The advantages, disadvantages, and risks of using a copper IUD.

The contraceptive efficacy of the copper IUD.

How to check for the device and its threads, and what to do if the woman is unable to feel the threads.

Advise the woman:

That heavier and/or prolonged bleeding and/or pain associated with copper IUD use can usually be treated.

That if menstrual abnormalities persist beyond the initial 6 months of use, she should seek medical advice to exclude infection and gynaecological pathology.

To seek medical advice if she experiences possible features of pelvic inflammatory disease (such as pain or tenderness in the lower abdomen, fever, abnormal or smelly vaginal discharge) especially within the first 3–4 weeks after insertion of the copper IUD.

That the copper IUD needs to be changed every 5–10 years (depending on which IUD is used).

That the device can be removed at any time if she wishes to become pregnant and there is no delay in return to fertility.

Also provide written information on the copper-bearing IUD.

The Family Planning Association provides a useful leaflet with information for users of the copper IUD — see www.fpa.org.uk.

Basis for recommendation

Basis for recommendation

These recommendations are based on the guidance The copper intrauterine device as long–term contraception issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare [FFPRHC, 2004a], and on the NICE guidance Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005].

Starting an IUD

Starting an intrauterine device

Assessment

How should I assess a woman's suitability to use an intrauterine device?

In young people (aged 18 years and under) and women with special needs, assess their competence to decide, and support them in making their own decisions about contraception.

For more information on prescribing to young women and women with special needs, see the sections on Prescribing to young people and Ethical and legal issues — learning disabilities in the CKS topic on Contraception - assessment.

Exclude pregnancy . If pregnancy is possible, do not insert the copper intrauterine device (IUD). Advise use of a barrier method (such as condoms) until pregnancy can be excluded.

If the woman does not wish to use a barrier method of contraception, consider one of the following options:

Combined hormonal contraception (pill [excluding co-cyprindiol], patch, or vaginal ring).

Progestogen-only pill.

Progestogen-only implant.

Progestogen-only injectables — if other methods are not appropriate or acceptable.

Check the UK Medical Eligibility Criteria to ensure that the woman is eligible for insertion of the IUD. This will require information from the medical record, clinical history, and clinical examination, which should include bimanual pelvic examination.

Although the copper IUD is a safe option in most women, there are a few cases where it:

Is contraindicated due to unacceptable health risks (UKMEC 4), for example woman with cervical cancer or active pelvic inflammatory disease.

Should be used with caution, and after consultation with an expert (UKMEC 3), for example women with uterine fibroids with distortion of the uterine cavity.

See Contraindications and cautions of the IUD for a full list of the UKMEC 3 and 4 categories.

Assess the woman's risk of sexually transmitted infections (STIs) and, when appropriate, advise testing, promote safer sex, and/or refer for sexual health counselling.

If the woman is at increased risk of STIs:

Counsel her (or arrange for counselling) about safe sexual practices.

Review her decision for choice of contraception, and discuss alternative contraceptive methods or recommend correct and consistent use of condoms with the copper IUD.

Test for Chlamydia trachomatis and, in women from areas where gonorrhoea is prevalent, test for Neisseria gonorrhoeae. If results of laboratory tests are not available, consider prophylactic antibiotics before inserting the device. For more information, see the CKS topics on Chlamydia - uncomplicated genital and Gonorrhoea.

If the woman requests testing for STIs, perform testing before inserting the device.

The following examinations and laboratory tests are not required to assess eligibility for the IUD:

Breast examination, cervical screening, and routine laboratory tests including haemoglobin and blood pressure screening.

If the woman has unexplained vaginal bleeding that suggests an underlying medical condition (such as bleeding between her periods or after sexual intercourse):

Do not insert the copper IUD until the cause of bleeding has been diagnosed.

Offer an alternative contraceptive method.

Training

Training

Healthcare professionals providing intrauterine or subdermal contraceptives should receive training to develop and maintain the relevant skills to provide these methods.

Intrauterine contraceptives such as the intrauterine device (IUD) should only be fitted by trained personnel with continuing experience of inserting at least one device a month.

Studies show that clinicians fitting less than 10 devices over a 6 year period have a higher rate of perforation than clinicians fitting between 10 and 100 devices.

[FSRH, 2007]

Basis for recommendation

Basis for recommendation

These recommendations are based mainly on the guidance The copper intrauterine device as long–term contraception and the UK Medical Eligibility Criteria for Contraceptive Use issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare [FFPRHC, 2004a; FSRH, 2009c], and on the NICE guidance Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005].

Unable to exclude pregnancy

The Clinical Effectiveness Unit of the FSRH advise that if pregnancy cannot be excluded, combined hormonal contraception (pill [excluding co-cyprindiol], patch, vaginal ring), progestogen-only pills, and progestogen-only implants can be prescribed if [FSRH, 2010b]:

'The woman is likely to continue to be at risk of pregnancy'.

'The woman has expressed a preference to begin contraception as soon as possible'.

If pregnancy cannot be excluded, women requesting the progestogen-only injectable should be offered a suitable bridging method because the injectable cannot be removed or stopped immediately if pregnancy is diagnosed. However, if there are no other suitable methods, the progestogen-only injectable can be considered.

Methods not recommended if pregnancy cannot be excluded:

Intrauterine contraception — because of the increased risk of miscarriage.

Co-cyprindiol (Dianette®) — although it has not been shown to be harmful to human fetuses, it is not licensed for use primarily as a contraceptive.

Women at higher risk of sexually transmitted infections

The recommendations about referring women at higher risk of sexually transmitted infections (STIs) for counselling are based on the NICE guideline One to one interventions to reduce the transmission of sexually transmitted infections including HIV, and to reduce the rate of under 18 conceptions, especially among vulnerable and at risk groups [NICE, 2007].

Consultations on contraception should opportunistically screen (using a sexual history) for individuals at high risk of STIs.

Individuals at high risk of STIs should be offered one to one structured discussions with a practitioner trained in sexual health.

UK Medical Eligibility Criteria

UK Medical Eligibility Criteria for the intrauterine device

The UK Medical Eligibility Criteria are a set of evidence-based recommendations designed to help women select the most appropriate method of contraception for specific clinical conditions without imposing unnecessary restrictions. Each clinical condition has a recommendation for contraceptive use, categorized according to the balance of benefits and harms weighted by their probabilities for the typical user with the condition. The categories are defined in Table 1. Table 2 describes the UK Medical Eligibility Criteria for use of a copper-bearing intrauterine device (IUD).

Table 1 . UK Medical Eligibility Criteria (UKMEC).
Category Definition
UKMEC 1 A condition for which there is no restriction for the use of the contraceptive method.
UKMEC 2 A condition where the advantages of using the method generally outweigh the theoretical or proven risks.
UKMEC 3 A condition where the theoretical or proven risks usually outweigh the advantages of using the method. Provision of a method to a woman with a condition given a UKMEC Category 3 requires expert clinical judgement and/or referral to a specialist contraceptive provider since use of the method is not usually recommended unless other methods are not available or not acceptable.
UKMEC 4 A condition which represents an unacceptable health risk if the contraceptive method is used.
Source: [FSRH, 2009c]
Table 2 . UK Medical Eligibility Criteria (UKMEC) for use of a copper intrauterine device (IUD).
Clinical feature UKMEC 1 No restrictions UKMEC 2 Advantages generally outweigh risks UKMEC 3 Requires expert clinical judgement UKMEC 4 Contraindicated
Pregnancy Pregnancy
Age >= 20 years Menarche to < 20 years
Parity Nulliparous Parous
Postpartum, breastfeeding or non-breastfeeding, including post-Caesarean Section >= 4 weeks 48 hours to < 4 weeks Puerperal sepsis
Post-abortion First-trimester abortion Second-trimester abortion Immediately after septic abortion
Ectopic pregnancy History of ectopic pregnancy
Smoking Past or current smoker
Obesity BMI >= 30 kg/m2
Blood pressure Adequately controlled hypertension Consistently elevated blood pressure systolic >140 mmHg or diastolic >90 mmHg Vascular disease History of high blood pressure during pregnancy
Surgery History of pelvic surgery Major surgery with or without prolonged immobilization Minor surgery without immobilization
Other risk factors for venous thromboembolism (VTE) History of VTE Current VTE (on anticoagulants) Family history of VTE in a first-degree relative Immobility (unrelated to surgery), for example wheelchair use, debilitating illness Known thrombogenic mutations, for example Factor V Leiden, Prothrombin mutation, Protein S, Protein C, Antithrombin deficiencies Varicose veins Superficial thrombophlebitis
Raynaud's disease Primary Secondary, with and without lupus anticoagulant
Systemic lupus erythematosus SLE alone Positive (or unknown) antiphospholipid antibodies For continuation Immunosuppressive treatment For initiation Immunosuppressive treatment For continuation Severe thrombocytopenia For initiation Severe thrombocytopenia
Headaches Non-migrainous headaches (mild or severe) Migraine headaches with or without aura, at any age History (>= 5 years ago) of migraine with aura, at any age
Epilepsy Epilepsy
Psychological conditions Depressive disorders
Breast disease Undiagnosed mass Benign breast disease or a family history of breast cancer Carriers of known gene mutations associated with breast cancer (for example BRCA1) Current breast cancer History of breast cancer and no evidence of recurrence for 5 years
Vaginal bleeding Irregular without heavy bleeding For initiation and continuation Heavy or prolonged bleeding (regular and irregular patterns) For continuation Unexplained vaginal bleeding (before evaluation) suspicious for serious underlying condition For initiation Unexplained vaginal bleeding (before evaluation) suspicious for serious underlying condition
Other gynaecological conditions Benign ovarian tumours including cysts Gestational trophoblastic disease when hCG is decreasing or normal Cervical ectropion CIN Uterine fibroids, without distortion of the uterine cavity For initiation and continuation Severe dysmenorrhoea Endometriosis Other abnormalities (including cervical stenosis or cervical lacerations) not distorting the uterine cavity or interfering with IUD insertion For continuation Cervical cancer, awaiting treatment Endometrial cancer Ovarian cancer Uterine fibroids, with distortion of the uterine cavity Distorted uterine cavity (any congenital or acquired uterine abnormality distorting the uterine cavity in a manner that is incompatible with IUD insertion) Initiation Ovarian cancer For initiation and continuation Gestational trophoblastic disease when hCG is persistently elevated or malignant disease For initiation Cervical cancer, awaiting treatment Endometrial cancer
Cardiovascular conditions Current and history of ischaemic heart disease Stroke including TIA Multiple risk factors for arterial cardiovascular disease Valvular and congenital heart disease: uncomplicated Valvular and congenital heart disease: complicated (e.g. by pulmonary hypertension, atrial fibrillation, or history of subacute bacterial endocarditis)
Gastrointestinal conditions History of cholestasis (related to pregnancy or combined oral contraceptive) Gallbladder disease: asymptomatic, symptomatic treated by cholecystectomy, medically treated, or current Cirrhosis: mild (compensated) or severe (decompensated) Liver tumours: benign (focal nodular hyperplasia; hepatocellular adenoma) and malignant (hepatoma) Inflammatory bowel disease
Infections For initiation and continuation Past pelvic inflammatory disease (with no risk factors for STIs) Schistosomiasis Non-pelvic tuberculosis Malaria Viral hepatitis: acute or flare, carrier or chronic disease For continuation Current pelvic inflammatory disease Chlamydia (symptomatic and asymptomatic) Current purulent cervicitis or gonorrhoea For initiation and continuation Other STIs (excluding HIV and hepatitis) Vaginitis Increased risk of STIs High risk of HIV HIV (not using antiretroviral therapy) HIV (using antiretroviral therapy)‡ AIDS For initiation HIV, using antiretroviral therapy‡ For continuation Known pelvic tuberculosis For initiation Current pelvic inflammatory disease Chlamydia (symptomatic and asymptomatic) Current purulent cervicitis or gonorrhoea Known pelvic tuberculosis
Diabetes mellitus History of gestational diabetes NIDDM and IDDM, non-vascular disease With nephropathy, retinopathy, or neuropathy; or other vascular disease
Thyroid Simple goitre, hypothyroid, hyperthyroid
Haematological conditions Anaemias: thalassaemia, iron deficiency, or sickle cell disease
Dyslipidaemia Known hyperlipidaemias
Antiretroviral therapy drug interactions (and consistent use of condoms is recommended) For initiation and continuation Nucleoside reverse transcriptase inhibitors Non-nucleoside reverse transcriptase inhibitors Ritonavir-boosted protease inhibitors For initiation Nucleoside reverse transcriptase inhibitors Non-nucleoside reverse transcriptase inhibitors Ritonavir-boosted protease inhibitors
Anticonvulsant therapy drug interactions Certain anticonvulsants (e.g. phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine) Lamotrigine
Antimicrobial therapy drug interactions Broad spectrum antibiotics Antifungals Antiparasitics Rifampicin or rifabutin therapy
BMI = body mass index; CIN = cervical intraepithelial neoplasia; hCG = human chorionic gonadotrophin; IDDM = insulin-dependent diabetes; IUD = intrauterine device; NIDDM = non-insulin-dependent diabetes; STI = sexually transmitted infection; SLE = systemic lupus erythematosus; TIA = transient ischaemic attack; VTE = venous thromboembolism. † The consistent use of condoms is recommended for women with HIV or AIDs on antiretroviral therapy, to prevent HIV transmission. ‡ HIV, using antiretroviral therapy is classified as Category 3 for initiation and Category 2 for continuation unless the woman is clinically well on antiretroviral therapy, in which case both initiation and continuation are classified as Category 2.
Data from: [FSRH, 2009c]

Contraindications and cautions of the IUD

Contraindications and cautions of the intrauterine device

Women should not use a copper IUD (UKMEC 4) in the following situations:

Pregnancy

Postpartum: puerperal sepsis

Post abortion: septic abortion

Unexplained vaginal bleeding: before evaluation when considering inserting a copper IUD. However, if the woman already has a copper IUD fitted it can be left in situ (UKMEC 2).

Gestational trophoblastic disease when the human chorionic gonadotropin level is persistently elevated or in malignant disease

Cervical cancer: awaiting treatment (when considering inserting a copper IUD. However, if the woman already has a copper IUD fitted it can be left in situ (UKMEC 2).

Endometrial cancer when considering inserting a copper IUD. However, if the woman already has a copper IUD fitted it can be left in situ (UKMEC 2).

Pelvic inflammatory disease: current

Sexually transmitted infections: current purulent cervicitis of gonorrhoea, asymptomatic or symptomatic chlamydial infection when considering inserting a copper IUD. However, if the woman already has a copper IUD fitted it can be left in situ (UKMEC 2).

Known pelvic tuberculosis when considering inserting a copper IUD. If the woman already has a copper IUD fitted it may need to be removed (UKMEC 3) — seek specialist advice.

Women should use a copper IUD only after consultation with an expert (UKMEC 3) in the following situations:

Postpartum: 48 hours to less than 4 weeks — delay inserting the copper IUD until 4 or more weeks after childbirth. Advise use of a barrier method of contraception (such as condoms) until then.

Uterine fibroids with distortion of the uterine cavity.

Distorted uterine cavity (any congenital or acquired uterine abnormality distorting the uterine cavity in a manner that is incompatible with IUD insertion).

HIV infected: using antiretroviral therapy — classified as UKMEC 3 for initiation and UKMEC 2 for continuation unless the woman is clinically well on antiretroviral therapy, in which case both initiation and continuation are classified as UKMEC 2.

Pelvic tuberculosis subsequently diagnosed: the copper IUD may need to be removed.

Ovarian cancer when considering inserting a copper IUD. However, if the woman already has a copper IUD fitted it can be left in situ (UKMEC 2).

Systemic lupus erythematosus with severe thrombocytopenia when considering inserting a copper IUD. However, if the woman already has a copper IUD fitted it can be left in situ (UKMEC 2).

If the woman has a history of endocarditis or a prosthetic heart valve:

Intravenous antibiotic prophylaxis is required at the time of insertion.

Basis for recommendation

Basis for recommendation

These recommendations are based on the UK Medical Eligibility Criteria for Contraceptive Use issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare [FSRH, 2009c].

When to insert— first use or switching

When can an intrauterine device be inserted?

First use

Insert the copper intrauterine device (IUD) at any time in the menstrual cycle if it is reasonably certain that the women is not pregnant.

An IUD is effective immediately so additional contraceptive protection will not be required.

If unprotected sexual intercourse occurred before insertion and there is a risk of conception, an IUD can safely be inserted up to 5 days after the first episode of sexual intercourse or up to 5 days after the earliest calculated time of ovulation.

If there is a delay before the IUD can be fitted:

Use a bridging method or advise the woman to use a barrier method of contraception (for example condoms) in the interim and reschedule the fitting to a mutually convenient time.

Combined hormonal contraception (pill, patch, or vaginal ring [not suitable post-partum if the woman is breastfeeding]), the progestogen-only pill, or the progestogen-only injectable can be used as a bridging method.

For more information, see the CKS topics on Contraception - combined hormonal methods and Contraception - progestogen-only methods.

Replacing an existing IUD with a new IUD

Replace the existing IUD with the new IUD at any time in the cycle. No additional contraceptive protection is required after insertion if the new IUD is inserted immediately after removing the existing IUD.

Advise the woman to use a barrier method of contraception (such as condoms) or abstain from sexual intercourse for 7 days prior to the replacement, in case the insertion fails.

Replacing an IUD with a levonorgestrel-releasing intrauterine system (IUS)

Replace the IUD with a levonorgestrel-releasing IUS at any time in the menstrual cycle provided it is reasonably certain that the woman is not pregnant. However, advise the woman to abstain from sexual intercourse or use a barrier method of contraception (such as condoms) for:

7 days before the procedure, in case reinsertion fails, and for

7 days after the insertion of the IUS, unless the IUS is inserted within the first 7 days of the onset of menstruation.

Switching from another contraceptive method

Insert the IUD at any time in the menstrual cycle provided that the other method of contraception has been used consistently and correctly, and it is reasonably certain that the woman is not pregnant.

There is no need to wait for the next menstrual period or withdrawal bleed.

No additional contraception is required.

Postpartum (including post-Caesarean section and breastfeeding)

Delay insertion until 4 weeks postpartum.

Advise women who are not fully breastfeeding to use another method of contraception from 21 days postpartum until insertion of the IUD.

Some experts suggest that insertion can also be considered immediately postpartum, or within the first 48 hours. However, expulsion is more common when the IUD is inserted soon after childbirth.

After abortion

Following surgical abortion:

Insert the IUD at the time of a first or second trimester surgical abortion for immediate contraceptive cover.

Following medical or surgical abortion:

The IUD can be inserted by an experienced clinician, any time following medical or a third trimester surgical abortion as long as there is no suspicion that the woman is still pregnant.

Otherwise, insertion should be done within the first 48 hours postpartum or delayed until 4 weeks postpartum.

Basis for recommendation

Basis for recommendation

These recommendations are based mainly on the guidelines The copper intrauterine device as long–term contraception and Intrauterine contraception issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare [FFPRHC, 2004a; FSRH, 2007], and on the National Institute for Health and Care Excellence (NICE) guidance Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005].

The advice on suitable bridging methods if there is a delay before an intrauterine device (IUD) can be fitted is taken from the Quick starting contraception guideline issued by the Faculty of Sexual and Reproductive Healthcare (FSRH) [FSRH, 2010b].

First use

A copper IUD is effective immediately after it is inserted because of the toxic effect of copper. If unprotected sexual intercourse occurred before insertion, and there is a risk of pregnancy, an IUD can safely be inserted if it is done before implantation (that is up to 5 days after the first episode of sexual intercourse or up to 5 days after the earliest calculated time of ovulation).

The advice on suitable bridging methods if there is a delay before an IUD can be fitted is taken from the Quick starting contraception guideline issued by the FSRH [FSRH, 2010b].

'If a woman’s method of choice cannot be started immediately, a short-acting method such as the combined hormonal contraception (pill, patch or vaginal ring) or the progestogen-only pill can be started as a bridging method until pregnancy has been excluded and the preferred method initiated' [FSRH, 2010b].

CKS recognizes that a bridging method may not always be possible, therefore, a barrier method can also be considered, and may be more acceptable to the woman, if there is a delay before an IUD can be fitted.

Additional contraceptive cover for 7 days after changing from an IUD to an IUS

The levonorgestrel-releasing IUS takes 7 days to provide effective contraceptive cover. Therefore, unless the IUS is inserted within the first 7 days of the onset of menstruation (when it is highly unlikely that the woman can get pregnant), the FSRH recommends an additional method of contraception or abstinence for 7 days after inserting the IUS [FSRH, 2007].

Additional contraceptive cover for 7 days before replacing an existing IUD with a new IUD or an IUS

The most likely time for becoming pregnant (fertile period) is from about 7 days before ovulation until about 2 days after ovulation, and sperm in a woman's reproductive tract can remain viable for up to 7 days [FPA, 2010]. If unprotected sexual intercourse occurs in the fertile period and reinsertion fails, the woman may become pregnant.

Inserting the IUD postpartum

Some experts suggest that insertion of an IUD can be considered within 48 hours of delivery. However, the FSRH advises that there may be an increased risk of uterine perforation if the IUD is inserted between 48 hours and 4 weeks postpartum [FFPRHC, 2004a]. In addition, the UK Medical Eligibility Criteria for inserting an IUD before 4 weeks postpartum is Category 3 which means that the risks generally outweighs the benefits [FSRH, 2009c].

Inserting the IUD after an abortion

In the past, the recommendation following a medical or surgical abortion, was to insert an IUD within the first 48 hours or delay until 4 or more weeks postpartum. However, the Clinical Effectiveness Unit (CEU) at the FSRH now recommend that after counselling and if the IUD is preferred, it can be inserted by an experienced clinician any time after abortion. This is because waiting until 4 or more weeks postpartum may put some women at risk of unwanted pregnancy [FSRH, 2007].

There is no evidence that there is an increased risk of uterine perforation if the IUD is inserted in the weeks following an abortion [FSRH, 2007].

Follow-up

What follow up is recommended following insertion of an intrauterine device?

Follow up the woman after the first menses, or 3–6 weeks after insertion, to exclude infection, perforation, or expulsion.

Consider the possibility of uterine perforation if a woman returns within the first few days of insertion complaining of marked pain (which may only be intermittent), and the threads cannot be located.

If uterine perforation is suspected, arrange an urgent ultrasound scan and/or abdominal X-ray to locate the device.

Advise the woman to return at any time if she:

Is unable to feel the threads of her copper intrauterine device (IUD).

Wants to change the method of contraception, or her IUD is due to be changed (after 5-10 years depending on the IUD)

Has missed her period, or has other reasons to think that she might be pregnant.

Has unscheduled bleeding or an unexpected change in pattern of bleeding — further investigations will be needed to exclude infection, pregnancy, and gynaecological pathology.

Basis for recommendation

Basis for recommendation

These recommendations are based on the guidance The copper intrauterine device as long–term contraception issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare [FFPRHC, 2004a], and on the National Institute for Health and Care Excellence (NICE) guidance Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005].

Duration of use

How long can the copper intrauterine device be left in place?

The copper intrauterine device (IUD) can be left in place for 5–10 years, depending on which device is used. See the manufacturer's Summary of Product Characteristics for more information.

Women who are aged 40 years or older at the time of IUD insertion may retain the device until they no longer require contraception, even if this is beyond the manufacturer's recommended duration of use:

Offer the woman the choice to continue with the IUD, replace the IUD, or use an alternative method of contraception.

Women younger than 50 years of age should continue contraception for 2 years after the last period.

Women aged 50 years or more should continue contraception for 1 year after the last period.

Basis for recommendation

Basis for recommendation

These recommendations are based on the guidance The copper intrauterine device as long–term contraception [FFPRHC, 2004a] and the guideline Contraception for women aged over 40 years [FSRH, 2010a] issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare.

IUD removal or replacement

When can the copper intrauterine device be safely removed or replaced?

If the woman wishes to become pregnant, remove the device at any time in the menstrual cycle.

If the woman does not wish to become pregnant, remove the device in the first few days after the onset of menstruation, or at any other time provided that there has been no unprotected sexual intercourse in the preceding 7 days.

If switching from the IUD to any other method of contraception, see the CKS topic for that method for more information.

Basis for recommendation

Basis for recommendation

These recommendations are based mainly on the guidelines The copper intrauterine device as long term contraception and Intrauterine contraception issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC) [FFPRHC, 2004a; FSRH, 2007], and the NICE guideline on Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005].

Most women using intrauterine contraception will still be ovulating so measures should be taken to reduce the risk of unwanted pregnancy. Women should be advised to arrange to have the device removed in the first few days after the onset of menstruation, or use condoms or abstain from intercourse for 7 days before removal of intrauterine contraception, even when reinsertion is planned [FSRH, 2007].

Unable to feel the threads

What should I do if the woman cannot feel the threads of her intrauterine device?

Do not assume expulsion.

Advise a barrier method of contraception (for example condoms) or abstinence until it is confirmed that the IUD is intrauterine (or not).

Consider the need for emergency contraception if sexual intercourse occurred in the 7 days prior to 'lost threads'. See the CKS topic on Contraception - emergency for more information.

Perform a vaginal examination.

If no threads are visible on speculum examination and uterine placement of the intrauterine device (IUD) cannot be confirmed clinically, refer the woman immediately for an urgent ultrasound scan to locate the device (advise a barrier method of contraception [for example condoms] or abstinence until the scan).

Experienced clinicians may use a thread retriever, Spencer Wells forceps, or uterine sonography to identify and retrieve the threads.

If ultrasonography cannot locate the device and there is no definite evidence of expulsion, arrange for an abdominal X-ray.

Advise a barrier method of contraception (for example condoms) or abstinence until the procedure.

If the device is extrauterine, or if partial perforation or embedment into the uterine wall is suspected, refer for surgical retrieval.

Advise a barrier method of contraception (for example condoms) or abstinence until the procedure.

Arrange for the woman to resume regular contraception after the procedure.

If the device is proven to be intrauterine, consider retaining the device or replacing with a new IUD.

If replacement is considered, discuss the risks of changing the device (such as infection, expulsion, and perforation).

Basis for recommendation

Basis for recommendation

These recommendations are based on the guidelines The copper intrauterine device as long–term contraception and Intrauterine contraception issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC) [FFPRHC, 2004a; FSRH, 2007].

Unscheduled bleeding

How should I manage unscheduled bleeding associated with use of the copper intrauterine device?

Spotting and light bleeding

Advise the woman that spotting or light bleeding is common during the first 3–6 months of copper intrauterine device (IUD) use, that it is not harmful, and that it usually decreases with time.

Consider a short course of a nonsteroidal anti-inflammatory drug (for example mefenamic acid) to be given during the days of bleeding. For prescriptions, see the CKS topic on Menorrhagia.

Heavy and/or prolonged menstruation

Consider prescribing a nonsteroidal anti-inflammatory drug (for example mefenamic acid) or an antifibrinolytic (for example tranexamic acid) to be taken during the days of bleeding. For prescriptions, see the CKS topic on Menorrhagia.

Do not prescribe aspirin.

If heavy bleeding remains unacceptable or if there is evidence of anaemia, consider changing to another method of contraception, such as the levonorgestrel-releasing intrauterine system.

Exclude or manage other situations which could result in unscheduled bleeding, such as:

Sexually transmitted infections (STIs). The risk of STIs is increased if the woman is under 25 years, has a new sexual partner, or has had more than one sexual partner in the last year.

Misplaced device.

Pregnancy.

Gynaecological conditions such as endometrial polyps, endometrial cancer, cervical cancer, or other gynaecological abnormality.

Speculum examination is warranted:

For persistent bleeding beyond the first 3–6 months of use.

For new symptoms or a change in bleeding after at least 3 months of use.

If the woman has not participated in a National Cervical Screening programme.

If requested by the woman.

If there are other symptoms such as pain, dyspareunia, or post coital bleeding. (Note that these symptoms also warrant pelvic examination.)

Refer if the cause of the bleeding cannot be determined or treated in primary care.

Basis for recommendation

Basis for recommendation

These recommendations are based mainly on The copper intrauterine device as long–term contraception issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare [FFPRHC, 2004a], the NICE guidance Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005], and on Clinical practice guidance for the assessment of young women aged 20-24 with abnormal vaginal bleeding issued by the Department of Health [DH, 2010].

On the basis of expert opinion, NICE recommends that if the woman finds the heavy bleeding associated with copper intrauterine device (IUD) use unacceptable, she should consider changing to the levonorgestrel-releasing intrauterine system [National Collaborating Centre for Women's and Children's Health, 2005].

The FSRH recommends that for women with spotting or light bleeding between menstrual periods, a short course of nonsteroidal anti-inflammatory drugs (NSAIDs) can be given during the days of bleeding [FFPRHC, 2002].

The FSRH advises that if abnormal bleeding persists for more than 6 months, gynaecological abnormality and infection should be excluded. Although a cohort study found that bleeding was not associated with a misplaced device on ultrasonography, this should still be considered in women with persistent bleeding [FFPRHC, 2004a].

Pregnant whilst using IUD

How should I manage a woman who becomes pregnant whilst using an intrauterine device?

If a woman is found to be pregnant whilst using a copper intrauterine device (IUD):

Exclude the possibility of an ectopic pregnancy.

Inform her that:

The risks of second trimester miscarriage, preterm delivery, and infection are increased if the device is left in situ.

The device should be removed within the first 12 weeks of gestation.

If the woman wishes to continue with the pregnancy:

Inform her that removal, where possible, would reduce adverse effects. However, removal itself carries a small risk of miscarriage.

Remove the device, provided that the woman understands the risks and agrees to removal.

Whether or not the device is removed, a pregnant woman should be advised to seek medical care if she develops heavy bleeding, cramping pain, abnormal vaginal discharge, or fever.

Basis for recommendation

Basis for recommendation

These recommendations are based on the guidelines The copper intrauterine device as long–term contraception and Intrauterine Contraception issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare [FFPRHC, 2004a; FSRH, 2007].

Most pregnancies that occur in women using an intrauterine device will be intrauterine, but ectopic pregnancy must be excluded [FSRH, 2009c].

Managing pelvic inflammatory disease

How should I manage pelvic inflammatory disease in a woman using a copper intrauterine device?

If pelvic inflammatory disease (PID) is diagnosed in a woman using the copper intrauterine device (IUD):

Test for the causative organism and start appropriate antibiotic treatment. For information on testing and antibiotics, see the CKS topic on Pelvic inflammatory disease.

Consider removing the IUD if the woman wishes for removal, or if symptoms have not resolved within 72 hours.

If a decision is made to remove the device and the woman has had sexual intercourse within the last 7 days, consider offering emergency hormonal contraception. For more information see the CKS topic on Contraception - emergency.

If the woman develops pelvic pain and has had actinomyces-like organisms (ALOs) identified on a smear in the past:

Take endocervical swabs, and urgently seek specialist advice regarding treatment.

Consider removal of the IUD.

Follow up all women with confirmed or suspected PID to ensure:

Resolution of symptoms and signs.

Completion of the course of antibiotics.

Risk assessment for sexually transmitted infections.

Counselling regarding safer sex.

Partner notification and treatment.

Basis for recommendation

Basis for recommendation

Removal of an intrauterine device

Recommendations about removing the copper intrauterine device (IUD) when a woman has pelvic inflammatory disease (PID) are based on expert opinion and are not entirely consistent among authorities:

Expert advice in the Faculty of Sexual and Reproductive Healthcare clinical guideline on intrauterine contraception does not routinely recommend the removal of an IUD. The Faculty's Clinical Effectiveness Unit supports the continued use of intrauterine contraception and appropriate antibiotic treatment if PID is suspected; there is no need to remove the IUD unless symptoms fail to resolve within 72 hours or the woman wants it removed [FFPRHC, 2006; FSRH, 2007].

Expert opinion in guidelines on the management of acute PID from the Royal College of Obstetricians and Gynaecologists [RCOG, 2009] advises that consideration be given to removing the IUD, especially if symptoms have not resolved within 72 hours.

The British Association for Sexual Health and HIV recommend considering removing the IUD if the woman develops PID. They advise balancing the decision to remove the IUD against the risk of pregnancy if the woman has had sexual intercourse in the preceding 7 days [BASHH, 2005].

Selected practice recommendations for contraceptive use from the World Health Organization state that [WHO, 2004]:

There is no need for removal of the IUD if the woman wishes to continue its use.

If the woman wishes removal, remove it after antibiotic treatment has been started.

If the infection does not improve then generally the course would be to remove the IUD and continue antibiotics. If the IUD is not removed then the antibiotic should be continued and the woman should be monitored closely.

Presence of actinomyces-like organisms (ALOs)

Expert opinion in guidelines from the Faculty of Sexual and Reproductive Healthcare is that [FSRH, 2007]:

The role of ALOs in infection in women using intrauterine contraception is unclear. Actinomyces israelii is a commensal organism in the female genital tract and although these organisms may be found on cervical smears or swabs, their presence is not diagnostic or predictive of infection. Therefore, there is no need to remove an IUD if the woman does not have symptoms.

If PID is suspected in a woman who has a history of ALOs on a cervical smear, it is important to consider that the infection may be due to other organisms.

It may be appropriate to remove the IUD.

Actinomyces-like organisms on a cervical smear

How should I manage a woman who has actinomyces-like organisms on a cervical smear and is using a copper intrauterine device?

If a woman who is using a copper intrauterine device (IUD) has actinomyces-like organisms (ALOs) seen on a cervical smear:

Assess her for signs and symptoms of pelvic inflammatory disease (PID) such as:

Lower abdominal pain and tenderness (usually the most prominent symptom).

Dyspareunia.

Abnormal vaginal bleeding (for example menorrhagia, postcoital, or intermenstrual bleeding).

Abnormal vaginal discharge.

Dysuria (pelvic inflammatory disease can occur with concurrent urethral chlamydial infection).

Nausea and vomiting (rare other than in acute infection).

If the woman is asymptomatic:

Advise her that it is not necessary to remove the device unless signs or symptoms of infection occur.

If the woman has symptoms of PID, see the CKS topic on Pelvic inflammatory disease.

Basis for recommendation

Basis for recommendation

These recommendations are based on the guidelines The copper intrauterine device as long–term contraception and Intrauterine Contraception issued by the Faculty of Sexual and Reproductive Healthcare, formerly the Faculty of Family Planning and Reproductive Healthcare [FFPRHC, 2004a; FSRH, 2007].

Advantages, disadvantages, and risks

What are the advantages, disadvantages, and risks of the copper intrauterine device (IUD)?

Advantages

Very safe.

Very effective .

Effective immediately after insertion; it can therefore also be used for emergency contraception.

Long-lasting: 5–10 years, depending on the product.

A single decision leads to effective long-term prevention of pregnancy. There is little for the user to remember once the device is inserted.

Sex need not be interrupted to use contraception.

There are no hormonal side effects.

Immediately reversible; normal fertility returns as soon as it is removed.

Can be used with breastfeeding.

Can be inserted from 4 weeks after childbirth (off-label use), irrespective of mode of delivery or immediately after first or second trimester abortion (by an experienced clinician).

Can be used by women of any age, and can be continued through the menopause.

There are no interactions with any medicines.

Disadvantages

An internal pelvic examination, prior to insertion of the device is needed to check that a copper IUD is suitable, and to insert the device.

There may be pain or discomfort for a few hours after insertion; this can be treated with an analgesic such as paracetamol or ibuprofen.

Some bleeding or spotting, may occur immediately after copper IUD insertion. This usually resolves in a day or two.

Some women experience severe cramps and pain beyond the first 3–5 days after insertion.

The woman cannot discontinue use on her own. A trained healthcare provider must remove the device.

The copper IUD does not protect against sexually transmitted infections, including HIV. However, the risk of HIV is not increased.

The IUD can be expelled without the woman knowing (although this is uncommon, less than 1 in 20 women in 5 years). It is important therefore that the woman checks for the presence of threads regularly (for example after every menstrual period). Some women may not want to do this internal examination.

Menstrual changes are common in the first 3 to 6 months but are likely to lessen after this time. Longer and heavier menstrual periods occur in most women, often with bleeding or spotting between periods, and more cramps or pain during periods.

Up to 50% of women have their copper intrauterine device (IUD) removed within 5 years, most commonly because of unacceptable vaginal bleeding and pain.

Some women may experience heavy menstrual bleeding or bleeding between periods, possibly contributing to anaemia. Nonsteroidal anti-inflammatory drugs and tranexamic acid are effective in the treatment of heavy bleeding with IUD use.

Risks

Perforation of the wall of the uterus. However, this is rare (occurs in less than 1 in 1000 women) and is dependent on the skills of the clinician.

Pelvic inflammatory disease follows insertion rarely (less than 1 in 100 women who are at low risk of sexually transmitted infections).

Ectopic pregnancy. Pregnancy with the device in place is rare (about 6 in 1000 women during the first year of perfect use), but when it does occur, the risk of the pregnancy being ectopic is about 1 in 20.

Basis for recommendation

Basis for recommendation

These recommendations are based on the guidance Intrauterine contraception issued by the Faculty of Sexual and Reproductive Healthcare [FSRH, 2007], on the NICE guidance Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005], information from a medical handbook [Hatcher et al, 1997], and expert opinion [Guillebaud, 2007].

Efficacy

How effective is the intrauterine device at preventing pregnancy?

For comparison of the efficacy of the intrauterine device with other methods, see Comparative efficacy.

When inserted correctly, 0.6% (6 out of 1000 women) will conceive within the first year of use due to method failure.

Comparative efficacy

Efficacy of different contraceptive methods

Table 1 . Summary of the efficacy of different contraceptive methods available in the UK, and their continuation rates (based on studies in the US)
Method Percentage of women experiencing an unintended pregnancy within the first year of use Percentage using the method 1 year after starting it
Typical use* Perfect use†
No method 85% 85%
Natural family planning 25% 1–9% depending on method 51%
Tablets (combined oral contraceptives and progestogen-only pill) 8% 0.3% 68%
Injectable medroxyprogesterone (Depo-Provera®) 3% 0.3% 56%
Etonogestrel implant 0.05% 0.05% 75%
Combination contraceptive patch 8% 0.3% 68%
Combined contraceptive vaginal ring 0.96 Pearl Index 0.64 Pearl Index
Copper intrauterine device (IUD): ParaGard (TCu 380A) 0.8% 2% cumulative pregnancy rate over 12 years 0.6% 2% cumulative pregnancy rate over 12 years 78%
Levonorgestrel-releasing intrauterine system (IUS) 0.1% 0.1% 81%
Diaphragm plus spermicide 16% 6% 57%
Cervical cap plus spermicide: Parous women Nulliparous women 32% 16% 20% 9% 46% 57%
Female condom (without spermicide) 21% 5% 49%
Male condom (without spermicide) 15% 2% 53%
Withdrawal 27% 4% 43%
Female sterilization 0.5% 1 in 200 lifetime-failure rate 0.5% 1 in 200 lifetime-failure rate 100%
Male sterilization 0.15% 1 in 700 lifetime-failure rate 0.05%§ 1 in 2000 lifetime-failure rate§ 100%
* The percentage of typical couples who start this method of contraception (not necessarily for the first time) and experience an accidental pregnancy during the first year (due to method failure, user failure, or provider failure), provided they do not stop for any other reason. † The percentage of couples who start this method of contraception (not necessarily for the first time) and who use it perfectly (both consistently and correctly) and experience an accidental pregnancy during the first year (due to method failure), provided they do not stop for any other reason. ‡ Pearl Indices (number of pregnancies per 100 woman years of use) found in clinical studies with Nuvaring® shows that the combined vaginal ring has a comparable efficacy with that known for combined oral contraceptives [ABPI Medicines Compendium, 2012b]. A Cochrane review comparing the combined contraceptive pill, patch, and vaginal ring also showed that all three methods have similar efficacy (0.3% when used perfectly and 8% when used typically) [Lopez et al, 2010]. § These figures are from the guideline Male and female sterilisation published by the Royal College of Obstetricians and Gynaecologists [RCOG, 2004] and information published by the Family Planning Association [FPA, 2011], and differ from the figures quoted in the reference below (1 in 1000 lifetime-failure rate, 0.10%) [National Collaborating Centre for Women's and Children's Health, 2005].
Data on failure rates are adapted from table 3.2 in [National Collaborating Centre for Women's and Children's Health, 2005], which adapted data from [Trussell, 2004]. Data on continuation rates are from the text of [National Collaborating Centre for Women's and Children's Health, 2005].

Basis for recommendation

Basis for recommendation

These recommendations are based on the NICE guideline Long–acting reversible contraception [National Collaborating Centre for Women's and Children's Health, 2005].

Evidence

Evidence

Search strategy

Scope of search

A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of contraception - IUS/IUD.

Search dates

2007 – December 2011.

Key search terms

Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline and these were adapted for other databases. Further details are available on request.

exp Contraception/, contraception.tw.

intrauterine system$.tw., IUS.tw., exp Intrauterine Devices/, intrauterine device$.tw., IUD.tw., coil.tw.

Table 1 . Key to search terms.
Search commands Explanation
/ indicates a MeSh subject heading with all subheadings selected
.tw indicates a search for a term in the title or abstract
exp indicates that the MeSH subject heading was exploded to include the narrower, more specific terms beneath it in the MeSH tree
$ indicates that the search term was truncated (e.g. wart$ searches for wart and warts)
Sources of guidelines

National Institute for Health and Care Excellence (NICE)

Scottish Intercollegiate Guidelines Network (SIGN)

Royal College of Physicians

Royal College of General Practitioners

Royal College of Nursing

NICE Evidence

Health Protection Agency

World Health Organization

National Guidelines Clearinghouse

Guidelines International Network

TRIP database

GAIN

NHS Scotland National Patient Pathways

New Zealand Guidelines Group

Agency for Healthcare Research and Quality

Institute for Clinical Systems Improvement

National Health and Medical Research Council (Australia)

Royal Australian College of General Practitioners

British Columbia Medical Association

Canadian Medical Association

Alberta Medical Association

University of Michigan Medical School

Michigan Quality Improvement Consortium

Singapore Ministry of Health

National Resource for Infection Control

Patient UK Guideline links

UK Ambulance Service Clinical Practice Guidelines

RefHELP NHS Lothian Referral Guidelines

Medline (with guideline filter)

Driver and Vehicle Licensing Agency

NHS Health at Work (occupational health practice)

Sources of systematic reviews and meta-analyses

The Cochrane Library :

Systematic reviews

Protocols

Database of Abstracts of Reviews of Effects

Medline (with systematic review filter)

EMBASE (with systematic review filter)

Sources of health technology assessments and economic appraisals

NIHR Health Technology Assessment programme

The Cochrane Library :

NHS Economic Evaluations

Health Technology Assessments

Canadian Agency for Drugs and Technologies in Health

International Network of Agencies for Health Technology Assessment

Sources of randomized controlled trials

The Cochrane Library :

Central Register of Controlled Trials

Medline (with randomized controlled trial filter)

EMBASE (with randomized controlled trial filter)

Sources of evidence based reviews and evidence summaries

Bandolier

Drug & Therapeutics Bulletin

TRIP database

Central Services Agency COMPASS Therapeutic Notes

Sources of national policy

Department of Health

Health Management Information Consortium (HMIC)

Patient experiences

Healthtalkonline

BMJ - Patient Journeys

Patient.co.uk - Patient Support Groups

Sources of medicines information

The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.

British National Formulary (BNF)

electronic Medicines Compendium (eMC)

European Medicines Agency (EMEA)

LactMed

Medicines and Healthcare products Regulatory Agency (MHRA)

REPROTOX

Scottish Medicines Consortium

Stockley's Drug Interactions

TERIS

TOXBASE

Micromedex

UK Medicines Information

References

ABPI Medicines Compendium (2012d) Summary of product characteristics for Mirena. Electronic Medicines CompendiumDatapharm Communications Ltd. www.medicines.org.uk [Free Full-text]

ABPI Medicines Compendium (2012y) Summary of product characteristics for Nuvaring. Electronic Medicines CompendiumDatapharm Communications Ltd. www.medicines.org.uk [Free Full-text]

ABPI Medicines Compendium (2012eo) Summary of product characteristics for Esmya 5 mg Tablets (ulipristal acetate). Electronic Medicines CompendiumDatapharm Communications Ltd. www.medicines.org.uk [Free Full-text]

ABPI Medicines Compendium (2012ep) Summary of product characteristics for ellaOne 30 mg. Electronic Medicines CompendiumDatapharm Communications Ltd. www.medicines.org.uk [Free Full-text]

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