Drs Lesley Curry (pictured) and Sharon Cameron summarise updated FSRH guidance on intrauterine contraception and discuss some implications for primary care
Intrauterine contraceptives (IUCs) are cost-effective, long-acting reversible methods of contraception (LARC), with licensed durations of use ranging between 3 and 10 years. They include nonhormonal intrauterine devices (IUDs), and hormonal intrauterine systems (IUSs). Intrauterine contraceptives include copper intrauterine devices (Cu-IUDs) and levonorgestrel intrauterine systems (LNG-IUSs). 1
Current national aims in contraceptive services are to increase uptake of LARC, including IUCs, to reduce the number of unintended pregnancies.2'Typical use' failure rates of IUCs are comparable with other long-acting methods, and there is a lower rate of contraceptive service use, making them more cost-effective than, for example, combined oral contraceptives. Novel ways of allowing women to access quality information regarding devices and insertion, such as on websites or via online videos, could potentially increase uptake and facilitate insertion at a single clinic visit.
Faculty of Sexual & Reproductive Healthcare guidance
In April 2015, the Faculty of Sexual & Reproductive Healthcare (FSRH) Clinical Effectiveness Unit (CEU) published updated guidance for healthcare professionals on Intrauterine contraception, updating 2007 guidance.1 The update includes evidence-based recommendations and good practice points for healthcare professionals on the use of IUCs currently available in the UK. Key changes in the update are:1
- inclusion of the 13.5 mg LNG-IUS3
- updated UK medical eligibility Criteria for contraceptive use (UKMEC)4
- updated advice on:
- sexually transmitted infection (STI) screening and timing of IUC insertion
- antibiotic prophylaxis for prevention of bacterial endocarditis
- interventions to ease IUC insertion
- new advice about women presenting late for replacement of the 52 mg LNG-IUS 5
- advice on IUC use in women with cardiac disease.
Intrauterine contraception—mode of action
The mode of action of an IUC is to cause a local response interfering with fertilisation. For the Cu-IUD this is mediated by the toxic copper effect on sperm and alterations in cervical mucus. For the LNG-IUS, the progesterone effect on the endometrium prevents implantation, and may also have an effect on cervical mucus. All IUCs may also provide a foreign body effect preventing implantation.1
In addition to information about the 52 mg LNG-IUS,5 which has been in use for some years, the updated FSRH guidance 1 now includes information about the 13.5 mg LNG-IUS (licensed for contraception only, and for 3 years of use only). 3
There is a very low failure rate associated with IUC (overall, 1–2:100 over 5 years' use). 2 Although the most effective methods are the 52 mg LNG-IUS and IUDs with 380 mm2 copper, there is no clinically significant difference in pregnancy rates.6 These rates are comparable to those of other LARCs. The pregnancy rate for the 13.5 mg LNG-IUS seems comparable, at 0.9:100 over 3 years.7
Copper IUDs are licensed for 5 or 10 years, depending on the device.2 The 52 mg LNG-IUS is licensed for 5 years, although the risk of pregnancy remains low up to 7 years post insertion.2,5 The 13.5 mg LNG-IUS is licensed for 3 years and there is no current recommendation on longer duration of use.2,3
Benefits of intrauterine contraception
In addition to providing effective contraception, IUC can provide noncontraceptive benefits. 1 The 52 mg LNG-IUS is licensed (for up to 4 years' use) for endometrial protection for women receiving oestrogen replacement therapy, and it can reduce the pain of dysmenorrhoea and endometriosis.5 (NB At the time of publication [April 2015], Mirena® 20 micrograms/24 hours [52 mg LNG-IUS] did not have UK marketing authorisation for reducing pain in dysmenorrhoea, endometriosis, or adenomyosis. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Good practice in prescribing medicines—guidance for doctors for further information. 8) The 52 mg LNG-IUS can also significantly reduce heavy menstrual bleeding. 9 The 13.5 mg LNG-IUS, however, is not a licensed treatment for heavy menstrual bleeding, and amenorrhoea is less likely than with the 52 mg LNG-IUS, possibly owing to the lower dose of levonorgestrel it delivers.1
Observational studies have shown that the risk of endometrial cancer may be reduced in users of the Cu-IUD.10 Although the progestogen content of an LNG-IUS should afford endometrial protection, the evidence for a reduced risk of endometrial cancer is not currently available.2
Before inserting the device
A woman's eligibility for IUCs can be checked using the UKMEC, and practitioners inserting these contraceptives should be familiar with up-to-date UKMEC criteria.1,4 In addition, consideration should be given to the risk of pregnancy and timing of insertion. TheSummary of product characteristics for both the 52 mg LNG-IUS5 and 13.5 mg LNG-IUS 3 state that the device is inserted into the uterine cavity within 7 days of the onset of menstruation.
An IUC can, however, be inserted at any time in the menstrual cycle if it is reasonably certain the patient is not pregnant or at risk of pregnancy (Box 1, below). When an LNG-IUS (i.e. the 52 mg or 13.5 mg LNG-IUS) is inserted after day 7 of the menstrual cycle, additional contraception should be used for 7 days.1 (NB At the time of publication [April 2015], Mirena® 20 micrograms/24 hours intrauterine delivery system [52 mg LNG-IUS] and Jaydess® 13.5 mg intrauterine delivery system did not have UK marketing authorisation for insertion beyond 7 days after the onset of menstruation. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Good practice in prescribing medicines—guidance for doctors for further information.8)
Box 1: Criteria for excluding pregancy1
- Healthcare professionals can be 'reasonably certain' that a woman is not currently pregnant if any one or more of the following criteria are met and there are no symptoms or signs of pregnancy:
- she has not had intercourse since last normal menses
- she has been correctly and consistently using a reliable method of contraception
- she is within the first 7 days of the onset of a normal menstrual period
- she is not breastfeeding and within less than 4 weeks of giving birth
- she is fully or nearly fully breastfeeding, amenorrhoeic, and less than 6 months post partum
- she is within the first 7 days post abortion or miscarriage
- A negative pregnancy test, if available, adds weight to the exclusion of pregnancy, but only if >3 weeks since the last episode of unprotected sexual intercourse.
NB In addition to the conditions mentioned above, healthcare professionals should also consider whether a woman is at risk of becoming pregnant as a result of unprotected sexual intercourse within the last 7 days.
- Faculty of Sexual & Reproductive Healthcare. Clinical Effectiveness Unit. Intrauterine contraception. FSRH, April 2015. Available at: www.fsrh.org.pdfs/CEUGuidanceIntrauterineContraception.pdf
No additional contraception is needed after insertion of a Cu-IUD, as the device is effective immediately. A Cu-IUD can be inserted up to day 5 after the earliest expected day of ovulation for emergency contraception if there is a risk of pregnancy; LNG-IUS cannot be used for emergency contraception.1 A bimanual and speculum examination should be performed at the time of insertion, but is not required at preceding visits.1
Removing or changing 52 mg LNG-IUS—updated evidence
If the 52 mg LNG-IUS is to be removed or changed, the evidence now suggests that the risk of pregnancy is likely to remain low in women who present late, i.e. between 5 and 7 years of use.1 The device can therefore be removed or changed without additional contraception, if a pregnancy test is negative; testing should take place at least 3 weeks following the last episode of unprotected intercourse. Women who retain their 13.5 mg LNG-IUS for more than 3 years should be advised to use additional precautions until pregnancy can be excluded.1 (NB At the time of publication [April 2015], Mirena® 20 micrograms/24 hours intrauterine delivery system [52 mg LNG-IUS] did not have UK marketing authorisation for use beyond 5 years. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Good practice in prescribing medicines—guidance for doctors for further information.8)
The updated FSRH guidance has also included evidence from NICE regarding the risk of bacterial endocarditis.11 People at risk of endocarditis include those with a previous history of endocarditis, valvular disease, or valve replacement, among others.12 Prophylactic antibiotics are now no longer routinely recommended before insertion of an IUC, because there is insufficient evidence to suggest they bring about a reduction in the incidence of endocarditis.11 However, case-by-case consideration is not excluded by this recommendation.
Vasovagal reaction and cardiac disease
The risk of vasovagal reaction with insertion is uncommon, and usually resolves spontaneously or with simple measures such as head-down tilt of the bed. 13 However, women with severe cardiac conditions or arrhythmias may not respond adequately to these measures, so insertion may represent a serious risk. The decision to use IUC should be balanced against the risk of pregnancy, and should involve a cardiology opinion. In patients at the highest risk, for example those who have Eisenmenger syndrome (right to left circulatory shunt due to structural defect), it is recommended that insertion should be done in a hospital setting. 1
The Royal College of Obstetricians and Gynaecologists has recommended that the IUC can be started immediately post abortion. The evidence suggests that immediate insertion of IUC at abortion is safe and associated with higher uptake of the method.14 Immediate insertion may be associated with slightly higher risk of expulsion, although there is no difference in other complication rates.15 The CEU recommends that IUCs can be inserted immediately if patients are told about this risk; they should be advised to check for threads.1
Sexually transmitted infection
All patients should be assessed for their risk of sexually transmitted infections (STIs). The British Association for Sexual Health and HIV publishes guidance on taking a sexual history.16 Risk factors may include:1
- age under 25 years
- new sexual partner in the past 3 months
- more than one partner in the last year
- regular sexual partner who has other sexual partners
- previous history or contact with an STI
- alcohol and substance abuse.
All sexually active women, however, should be offered STI screening, with chlamydia testing as a minimum. In many centres a single self-obtained vaginal swab can be sent for combined chlamydia and gonorrhoea nucleic acid amplification testing (NAAT). Syphilis and HIV screening should also be offered routinely. 1
The CEU has revised guidance on prophylactic antibiotic treatment prior to availability of screening results, based upon a recent Cochrane review that reported a low incidence of infection related to IUC insertion, with or without prophylaxis. 17 The recommendation is that an IUC may be inserted without prophylactic treatment if:1
- screening results are unavailable
- the patient is asymptomatic and can be contacted for prompt treatment when the results are available.
For women who have symptoms of possible STI infection and/or pelvic inflammatory disease, insertion should be delayed until results of swabs are available, symptoms have subsided, and treatment has been given. In women who have a positive chlamydia or gonorrhoea result, intrauterine contraception can be inserted if the patient is asymptomatic and has completed antibiotic treatment.1 In women with asymptomatic chlamydia, insertion in an emergency situation is acceptable providing antibiotics are given at the time.1
There is no indication to screen for other lower genital infections in asymptomatic women. A few cases of severe (life-threatening) infection have been reported following IUC insertion from group A streptococcal disease. Although there is no indication to screen for this, if women are found to be carrying group A streptococcus, it is recommended that treatment is given and insertion of the IUC is delayed.1
Facilitating safe insertion
The CEU has updated the evidence on interventions to facilitate safe insertion.1 A range of potential interventions has been assessed, including use of cervical ripening agents, prophylactic oral analgesia, and bladder filling; there is no evidence to support the routine use of these to aid insertion. Pain can be a significant patient concern regarding IUC insertion.18 Current practice is varied in the use of local anaesthetic block prior to insertion. There is no routine requirement for its use but it should be offered when a difficult insertion is anticipated. Non-steroidal anti-inflammatory drugs can be offered to women experiencing pain following insertion. 1
A bimanual examination is required for all women; however, there is no evidence to support cervical cleansing, providing a no-touch technique is used. The use of tissue forceps on the cervix is recommended to ease insertion and reduce the risk of perforation, although there is no evidence to support any particular type.1
Intrauterine contraception insertions are generally safe procedures, although insertion is known to be a trigger for vasovagal response.13 All staff involved in insertion should undergo regular training and updates in resuscitation.
There is no specific recommendation on the availability and use of intravenous atropine, but this has been addressed elsewhere in service standards.19
Problems presenting to primary care
Many women will attend primary care in the first instance for concerns regarding IUC, and the CEU has provided some clarification in the updated guidance on commonly encountered problems.
Threads cannot be felt
Intrauterine contraception threads may not be felt by the woman, nor be visible on examination. This may be due to expulsion of the device, pregnancy, perforation, or retraction of the threads into the endocervical canal. In the first instance, pregnancy should be excluded, additional precautions advised, and an ultrasound scan arranged; this should be done prior to attempting 'blind' thread retrieval. If the device is confirmed to be within the uterine cavity, the woman can be reassured and the device left in place, if desired. If retrieval is required and cannot be easily performed, referral to a specialist centre is recommended.1
Perforation may be suspected at the time of insertion, or there may be a delay in identifying a perforation. Continuing abdominal pain, lost threads, changes in bleeding, or a history of pain at insertion should all raise the suspicion, and an ultrasound scan arranged to check the placement of the device as soon as possible. Additional contraception should also be advised.1
New advice has been given for devices found to be non-fundally placed (lowlying) on ultrasound scan. Although the evidence is limited, a low-lying IUC cannot be guaranteed to provide adequate contraceptive cover. In theory the LNG-IUS may remain effective in low positions; however the consensus of the CEU is that the contraceptive effect cannot be guaranteed. The decision to remove and replace a device should therefore be taken on an individual basis in conjunction with the patient. Consideration as to timing of intercourse and the need for emergency contraception should be given.1
Implications for primary care
Considerable time is needed to ensure patients are fully informed of the risks and benefits of IUC. Up to three appointments may be needed for counselling and insertion. There may be a further pressure on primary care to ensure that assistants are available who are trained in emergency care. Given the pressures on appointments in general practice, the use of alternative counselling and consent options may be needed (e.g. via the practice website or through written information). The traditional follow-up visit, however, is no longer essential (women can self-check for threads), which will free up practice resources. 1
Many practices already offer appropriate screening for chlamydia and gonorrhoea; however, the updated guidance suggests offering HIV and syphilis screening to all patients,1 and this may generate an increased practice workload and identify additional training needs. The new online learning resources (e-SRH training programme) from the FSRH may help to address this.20
Health professionals are recommended to complete training in the Letter of Competence from the FSRH, or equivalent training, and demonstrate evidence for recertification. Those who do not hold the FSRH diploma may still certify for the Letter of Competence after taking an electronic knowledge assessment (eKA), details of which may be found on the faculty website.21 A minimum of twelve insertions in 12 months is required in order to maintain competence. Practices may need to give consideration to allowing staff to maintain their skills.
Intrauterine contraceptives remain highly effective at preventing pregnancy, with a range of non-contraceptive benefits. The challenges of providing this service in general practice remain, but use of newer training methods and alternative resources for counselling may facilitate service provision.
- Both a medical and sexual history should be taken to determine a woman's suitability for IUC
- Women identified with risk factors for bacterial endocarditis no longer require routine prophylactic antibiotics
- Intrauterine contraceptives can be inserted immediately post abortion, providing women are advised of a slightly higher expulsion rate; they should be advised to check for threads
- All sexually active women should have an STI assessment, and be offered screening for chlamydia, gonorrhoea, HIV, and syphilis
- asymptomatic patients may have an IUC inserted prior to availability of screening results without prophylactic antibiotics
- There is no need to delay insertion for asymptomatic patients with positive chlamydia or gonorrhoea results, providing antibiotic treatment has been completed
- It is no longer essential to offer a routine follow-up; however, patients should be advised about signs and symptoms of complications and to check for the presence of threads
- Consider the training needs of staff performing and assisting with insertions, including training in managing emergencies at insertion.
CP commissioning messages
written by Dr David Jenner, NHS Alliance GMS contract/PBC Lead
- Intrauterine devices are safe, efficient, and cost effective forms of LARC and commissioners should ensure they are readily available to local populations
- The responsibility for commissioning and funding their use as contraception lies with departments of public health in local authorities
- These forms of contraception can be offered in most general practices but departments of public health will need to ensure other alternatives are available where general practices do not offer these services, e.g. through well woman clinics or genitourinary medicine clinics
- In future, these services may be contracted for at scale by public health and this is where GP practices may need to federate to bid for such services.
LARC=long-acting reversible contraception
- Faculty of Sexual & Reproductive Healthcare. Clinical Effectiveness Unit. Intrauterine Contraception. FSRH, April 2015. Available at: www.fsrh.org/pdfs/CEUGuidanceIntrauterineContraception.pdf
- NICE. Long-acting reversible contraception (update). Clinical Guideline 30. NICE, 2014. Available at: www.nice.org.uk/guidance/CG30
- Electronic Medicines Compendium. Jaydess® 13.5 mg intrauterine delivery system: Summary of product characteristics. www.medicines.org.uk/emc/medicine/28672/SPC/Jaydess+13.5+mg+intrauterine+delivery+system (accessed 22 April 2015].
- Faculty of Sexual & Reproductive Healthcare.UK medical eligibility criteria for contraceptive use. UKMEC 2009. FSRH, 2009. Available at:www.fsrh.org/pdfs/UKMEC2009.pdf
- Electronic Medicines Compendium. Mirena®. Summary of product characteristics. 2013. www.medicines.org.uk/emc/medicine/1829 (accessed 23 April 2015).
- French R, Sorhaindo A, Van Vliet H et al. Progestogen-releasing intrauterine systems versus other forms of reversible contraceptives for contraception. Cochrane Database Syst Rev 2004; (3): CD001776.
- Faculty of Sexual & Reproductive Healthcare. New product review from the clinical effectiveness unit. Jaydess® levonorgestrel intrauterine system (LNG-IUS). FSRH, April 2014. Available at: www.fsrh.org/pdfs/CEUProductReviewJaydess. pdf (accessed 6 May 2015).
- General Medical Council. Good practice in prescribing and managing medicines and devices. London: GMC, 2013. Available at: www.gmcuk. org/guidance/ethical_guidance/14316.asp (accessed 23 April 2015).
- NICE. Heavy menstrual bleeding. Clinical Guideline 44. NICE, 2007. Available at: www.nice.org.uk/guidance/cg44
- Beining R , Dennis L, Smith E, Dokras A. Meta-analysis of intrauterine device use and risk of endometrial cancer. Ann Epidemiol 2008; 18 (6): 492–499.
- NICE. Prophylaxis against infective endocarditis. Antimicrobial prophylaxis against infective endocarditis in adults and children undergoing interventional procedures. Clinical Guideline 64. NICE, 2008. Available at: www.nice.org.uk/guidance/cg64
- Faculty of Sexual & Reproductive Healthcare. Contraceptive choices for women with cardiac disease. FSRH, 2014. Available at: www.fsrh.org/ pdfs/CEUGuidanceContraceptive ChoicesWomenCardiacDisease.pdf
- Baird, A, Dickson J, Jensen M, Talbot M. Syncope and profound bradycardia associated with intrauterine contraceptive procedures. J Fam Plann Reprod Health Care 2012; 38: 191–193 doi: 10.1136/jfprhc-2011-100205
- Royal College of Obstetricians and Gynaecologists. The care of women requesting induced abortion. London: RCOG, 2011. Available at www.rcog.org.uk/globalassets/ documents/guidelines/abortion-guideline_ web_1.pdf
- Grimes D, Lopez L, Schulz K, Stanwood N. Immediate postabortal insertion of intrauterine devices. Cochrane Database Syst Rev 2004; (4): CD001777.
- Brook G, Bacon L, Evans C et al. Clinical Effectiveness Group British Association for Sexual Health and HIV. 2013 UK national guideline for consultations requiring sexual history taking. Int J STD AIDS 2014; 25 (6): 391–404.
- Grimes D, Lopez L, Schulz K. Antibiotic prophylaxis for intrauterine contraceptive device insertion. Cochrane Database Syst Rev 2001; (1): CD001327
- Aksoy H, Aksoy U, Ozyurt S et al. Lidocaine 10% spray to the cervix reduces painduring intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care doi: 10.1136/jfprhc-2014-100917.
- Faculty of Sexual & Reproductive Healthcare.Service standards for resuscitation in sexual and reproductive healthcare services. FSRH, 2013. Available at: www.fsrh.org/pdfs/Resucitation_ January_2013.pdf (accessed April 2015).
- Faculty of Sexual & Reproductive Healthcare. e-Learning for Healthcare. e-SRH Sexual & Reproductive Healthcare e-learning. Available at: www.e-lfh.org.uk/programmes/ sexual-and-reproductive-healthcare
- Faculty of Sexual & Reproductive Healthcare. Letter of competence in intrauterine techniques. Available at: www.fsrh.org/pages/Letter_of_ Competence_IUT.asp