The levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, and 4) and recommendation grades (A-D and D(GPP))are defined at the end of the "Major Recommendations" field.
Contraceptive Use and Principles of Care
Contraceptive Provision
D(GPP) - Women requiring contraception should be given information about and offered a choice of all methods, including long-acting reversible contraception (LARC) methods.
D(GPP) - Women should be provided with the method of contraception that is most acceptable to them provided it is not contraindicated.
C - Contraceptive service providers should be aware that:
- All currently available LARC methods (intrauterine devices [IUDs], the intrauterine system [IUS], injectable contraceptives and implants) are more cost effective than the combined oral contraceptive pill even at 1 year of use
- IUDs, the IUS and implants are more cost effective than the injectable contraceptives
- Increasing the uptake of LARC methods will reduce the number of unintended pregnancies
Provision of Information and Informed Choice
D(GPP) - Women considering LARC methods should receive detailed information - both verbal and written – that will enable them to choose a method and use it effectively. This information should take into consideration their individual needs and should include:
- Contraceptive efficacy
- Duration of use
- Risks and possible side effects
- Non-contraceptive benefits
- The procedure for initiation and removal/discontinuation
- When to seek help while using the method
D(GPP) - Counselling about contraception should be sensitive to cultural differences and religious beliefs.
D(GPP) - Healthcare professionals should have access to trained interpreters for women who are not English speaking, and to advocates for women with sensory impairments or learning disabilities.
Contraceptive Prescribing
D(GPP) - A medical history - including relevant family, menstrual, contraceptive and sexual history - should be taken as part of the routine assessment of medical eligibility for individual contraceptive methods.
D(GPP) - Healthcare professionals helping women to make contraceptive choices should be familiar with nationally agreed guidance on medical eligibility and recommendations for contraceptive use.
D(GPP) - When considering choice of LARC methods for specific groups of women and women with medical conditions, healthcare professionals should be aware of and discuss with each woman any issues that might affect her choice.
D(GPP) - Healthcare professionals should exclude pregnancy by taking the menstrual and sexual history before initiating any contraceptive methods.
D(GPP) - Healthcare professionals should supply an interim method of contraception at the first appointment if required.
D(GPP) - Healthcare professionals should ensure that informed consent is obtained from the woman whenever any method of LARC is being used outside the terms of the United Kingdom (UK) Marketing Authorisation. This should be discussed and documented in the notes.
D(GPP) - Women who have a current venous thromboembolism (VTE) and need hormonal contraception while having treatment for the VTE should be referred to a specialist in contraceptive care.
Contraception and Sexually Transmitted Infection
D(GPP) - Healthcare professionals providing contraceptive advice should promote safer sex.
D(GPP) - Healthcare professionals providing contraceptive advice should be able to assess risk for sexually transmitted infections (STIs) and advise testing when appropriate.
D(GPP) - Healthcare professionals should be able to provide information about local services for STI screening, investigation and treatment.
Contraception for Special Groups
D(GPP) - Healthcare professionals should be aware of the law relating to the provision of advice and contraception for young people and for people with learning disabilities. Child protection issues and the Fraser guidelines should be considered when providing contraception for women younger than 16 years.*
*Note: See the Department of Health's Best Practice Guidance for Doctors and Other Health Professionals on the Provision of Advice and Treatment to Young People under 16 on Contraception, Sexual and Reproductive Health (July 2004), available from www.dh.gov.uk.
D(GPP) - Women with learning and/or physical disabilities should be supported in making their own decisions about contraception.
D(GPP) - Contraception should be seen in terms of the needs of the individual rather than in terms of relieving the anxieties of carers or relatives.
D(GPP) - When a woman with a learning disability is unable to understand and take responsibility for decisions about contraception, carers and other involved parties should meet to address issues around the woman's contraceptive need and to establish a care plan.
Training of Health Professionals in Contraceptive Care
D(GPP) - Healthcare professionals advising women about contraceptive choices should be competent to:
- Help women to consider and compare the risks and benefits of all methods relevant to their individual needs
- Manage common side effects and problems
D(GPP) - Contraceptive service providers who do not provide LARC in their practice or service should have an agreed mechanism in place for referring women for LARC.
D(GPP) - Healthcare professionals providing intrauterine or subdermal contraceptives should receive training to develop and maintain the relevant skills to provide these methods.
C - IUDs and the IUS should only be fitted by trained personnel with continuing experience of inserting at least one IUD or one IUS a month.
D(GPP) - Contraceptive implants should be inserted and removed only by healthcare professionals trained in the procedure.
Copper Intrauterine Devices
Decision Making
Women should be given the following information.
Contraceptive Efficacy
- C - IUDs act by preventing fertilisation and inhibiting implantation.
- D - The licensed duration of use for IUDs containing 380 mm2 copper ranges from 5 to 10 years, depending on the type of device.
- C - The pregnancy rate associated with the use of IUDs containing 380 mm2 copper is very low (fewer than 20 in 1000 over 5 years).
- C - There is no evidence of a delay in the return of fertility following removal or expulsion of IUDs.
Effect on Periods
- C - Heavier bleeding and/or dysmenorrhoea are likely with IUD use.
Risks and Possible Side Effects
- C - Up to 50% of women stop using IUDs within 5 years; the most common reasons for discontinuation are unacceptable vaginal bleeding and pain.
- C - There is no evidence that IUD use affects weight.
- C - Any changes in mood and libido are similar whether using IUDs or the IUS, and the changes are small.
- D - The risk of uterine perforation at the time of IUD insertion is very low (less than 1 in 1000).
- C - The risk of developing pelvic inflammatory disease following IUD insertion is very low (less than 1 in 100) in women who are at low risk of STIs.
- C - IUDs may be expelled but this occurs in fewer than 1 in 20 women in 5 years.
- D - The risk of ectopic pregnancy when using IUDs is lower than when using no contraception.
- C - The overall risk of ectopic pregnancy when using the IUD is very low, at about 1 in 1000 in 5 years.
- C - If a woman becomes pregnant with the IUD in situ, the risk of ectopic pregnancy is about 1 in 20, and she should seek advice to exclude ectopic pregnancy.
Other Issues to Consider before Fitting an IUD
D - 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 duration of the UK Marketing Authorisation.*
*Note: Check the Summary of Product Characteristics of individual devices for current licensed indications. Informed consent is needed when using outside the licensed indications. This should be discussed and documented in the notes.
D(GPP) - Contraceptive care providers should be aware that the risk of perforation is related to the skill of the healthcare professional inserting the IUD.
D(GPP) - Testing for the following infections should be undertaken before IUD insertion:
- Chlamydia trachomatis in women at risk of STIs
- Neisseria gonorrhoeae in women from areas where the disease is prevalent and who are at risk of STIs
- Any STIs in women who request it
D(GPP) - If testing for STIs is not possible, or has not been completed, prophylactic antibiotics should be given before IUD insertion in women at increased risk of STIs.
D(GPP) - Women with identified risks associated with uterine or systemic infection should have investigations, and appropriate prophylaxis or treatment before insertion of an IUD.
Specific Groups, Medical Conditions and Contraindications
D(GPP) - IUDs may be used by adolescents, but STI risk should be considered where relevant.
Healthcare professionals should be aware that:
- D(GPP) - IUD use is not contraindicated in nulliparous women of any age.
- D(GPP) - Women of all ages may use IUDs.
- C - IUDs can safely be used by women who are breastfeeding.
Healthcare professionals should be aware that:
- D(GPP) - IUD use is not contraindicated in women with diabetes.
- D(GPP) - IUD use is a safe and effective method of contraception for women who are human immunodeficiency virus (HIV)-positive or have acquired immune deficiency syndrome (AIDS) (safer sex using condoms should be encouraged in this group).
Practical Details of Fitting IUDs
B - The most effective IUDs contain at least 380 mm2 of copper and have banded copper on the arms. This, together with the licensed duration of use, should be considered when deciding which IUD to use.
D(GPP) - Provided that it is reasonably certain that the woman is not pregnant, IUDs may be inserted:
- At any time during the menstrual cycle
- Immediately after first- or second-trimester abortion, or at any time thereafter
- From 4 weeks postpartum, irrespective of the mode of delivery
D(GPP) - Emergency drugs including anti-epileptic medication should be available at the time of IUD insertion in a woman with epilepsy because there may be an increased risk of a seizure at the time of cervical dilation.
Advice for Women at Time of Fitting
D(GPP) - Women should be informed:
- About symptoms of uterine perforation or infection that would warrant an early review of IUD use
- That insertion of an IUD may cause pain and discomfort for a few hours and light bleeding for a few days, and they should be informed about appropriate pain relief
- About how to check for the presence of IUD threads and encouraged to do this regularly with the aim of recognising expulsion
Follow-Up and Managing Problems
D(GPP) - A follow-up visit should be recommended after the first menses, or 3-6 weeks after insertion, to exclude infection, perforation or expulsion. Thereafter, a woman should be strongly encouraged to return at any time to discuss problems, if she wants to change her method of contraception, or if it is time to have the IUD removed.
B - Heavier and/or prolonged bleeding associated with IUD use can be treated with nonsteroidal anti-inflammatory drugs and tranexamic acid.
D(GPP) - Women who find heavy bleeding associated with IUD use unacceptable may consider changing to a levonorgestrel intrauterine system (LNG-IUS).
D(GPP) - The presence of Actinomyces-like organisms on a cervical smear in a woman with a current IUD requires an assessment to exclude pelvic infection. Routine removal is not indicated in women without signs of pelvic infection.
D(GPP) - Women who have an intrauterine pregnancy with an IUD in situ should be advised to have the IUD removed before 12 weeks' completed gestation, whether or not they intend to continue the pregnancy.
Intrauterine System
Decision Making
Women should be given the following information.
Contraceptive Efficacy
- D(GPP) - The IUS may act predominantly by preventing implantation and sometimes by preventing fertilisation.
- C - The pregnancy rate associated with the use of the IUS is very low (fewer than 10 in 1000 over 5 years).
- D - The licensed duration of use for IUS is 5 years for contraception.
- C - There is no evidence of a delay in the return of fertility following removal or expulsion of the IUS.
Effects on Periods
- C - Irregular bleeding and spotting are common during the first 6 months following IUS insertion.
- C - Oligomenorrhoea or amenorrhoea is likely by the end of the first year of IUS use.
Risks and Possible Side Effects
- C - Up to 60% of women stop using the IUS within 5 years. The most common reasons are unacceptable vaginal bleeding and pain; a less common reason is hormonal (non-bleeding) problems.
- C - There is no evidence that IUS use causes weight gain.
- C - Any changes in mood and libido are similar whether using the IUS or IUDs, and the changes are small.
- C - There may be an increased likelihood of developing acne as a result of absorption of progestogen, but few women discontinue IUS use for this reason.
- D - The risk of uterine perforation at the time of IUS insertion is very low (less than 1 in 1000).
- C - The risk of developing pelvic inflammatory disease following IUS insertion is very low (less than 1in 100) in women who are at low risk of STIs.
- C - The IUS may be expelled, but this occurs in fewer than 1 in 20 women in 5 years.
- D - The risk of ectopic pregnancy when using the IUS is lower than when using no contraception.
- C - The overall risk of ectopic pregnancy when using the IUS is very low, at about 1 in 1000 in 5 years.
- D(GPP) - If a woman becomes pregnant with the IUS in situ, the risk of ectopic pregnancy is about 1 in 20, and she should seek advice to exclude ectopic pregnancy.
Other Issues to Consider Before Fitting an IUS
D - Women who are aged 45 years or older at the time of IUS insertion and who are amenorrhoeic may retain the device until they no longer require contraception, even if this is beyond the duration of UK Marketing Authorisation.*
*Note: Check the Summary of Product Characteristics for current licensed indications. Informed consent is needed when using outside the licensed indications. This should be discussed and documented in the notes.
D(GPP) - Contraceptive care providers should be aware that the risk of perforation is related to the skill of the healthcare professional inserting the IUS.
D(GPP) - Testing for the following infections should be undertaken before IUS insertion:
- Chlamydia trachomatis in women at risk of STIs
- Neisseria gonorrhoeae in women from areas where the disease is prevalent and who are at risk of STIs
- Any STIs in women who request it
D(GPP) - If testing for STIs is not possible, or has not been completed, prophylactic antibiotics should be given before IUS insertion in women at increased risks of STIs.
D(GPP) - Women with identified risks associated with uterine or systemic infection should have investigations, and appropriate prophylaxis or treatment before insertion of the IUS.
Specific Groups, Medical Conditions and Contraindications
D(GPP) - The IUS may be used by adolescents, but STI risk should be considered where appropriate.
Healthcare professionals should be aware that:
- D(GPP) - IUS use is not contraindicated in nulliparous women of any age.
- D(GPP) - Women of all ages may use the IUS.
- D - The IUS can safely be used by women who are breastfeeding.
Healthcare professionals should be aware that:
- D - There is no evidence that the effectiveness of the IUS is reduced when taking any other medication.
- D(GPP) - IUS use is not contraindicated in women with diabetes.
- D(GPP) - IUS is a safe and effective method of contraception for women who are HIV-positive or have AIDS (safer sex using condoms should be encouraged in this group).
- D(GPP) - All progestogen-only methods, including the IUS, may be used by women who have migraine with or without aura.
- D(GPP) - Women with a history of venous thromboembolism may use the IUS.
- D(GPP) - IUS is medically safe for women to use if oestrogen is contraindicated.
Practical Details of Fitting the IUS
D(GPP) - Provided that it is reasonably certain that the woman is not pregnant, the IUS may be inserted:
- At any time during the menstrual cycle (but if the woman is amenorrhoeic or it has been more than 5 days since menstrual bleeding started, additional barrier contraception should be used for the first 7 days after insertion)
- Immediately after first- or second-trimester abortion, or at any time thereafter
- From 4 weeks postpartum, irrespective of the mode of delivery.*
*Note: At the time of publication (October 2005), use before 6 weeks postpartum was outside the UK marketing authorisation for the IUS. Check the Summary of Product Characteristics for current licensed indications. Informed consent is needed when using outside the licensed indications. This should be discussed and documented in the notes.
D(GPP) - Emergency drugs including anti-epileptic medication should be available at the time of IUS insertion in a woman with epilepsy because there may be an increased risk of a seizure at the time of cervical dilation.
Advice for Women at Time of Fitting
Women should be informed:
- D(GPP) - About symptoms of uterine perforation or infection that would warrant an early review of IUS use
- D(GPP) - That insertion of an IUS may cause pain and discomfort for a few hours and light bleeding for a few days, and they should be informed about appropriate pain relief
- D(GPP) - About how to check for the presence of IUS threads, and encouraged to do this regularly with the aim of recognising expulsion.
Follow-up and Managing Problems
D(GPP) - A follow-up visit should be recommended after the first menses, or 3-6 weeks after insertion, to exclude infection, perforation or expulsion. Thereafter, a woman should be strongly encouraged to return at any time to discuss problems, if she wants to change her method of contraception, or if it is time to have the IUS removed.
D(GPP) - The presence of Actinomyces-like organisms on a cervical smear in a woman with a current IUS requires an assessment to exclude pelvic infection. Routine removal is not indicated in women without signs of pelvic infection.
D(GPP) - Women with an intrauterine pregnancy with an IUS in situ should be advised to have the IUS removed before 12 completed weeks of gestation whether or not they intend to continue the pregnancy.
Progestogen-Only Injectable Contraceptives (POICs)
Decision Making
Women should be given the following information.
Contraceptive Efficacy
Effects on Periods
- C - Amenorrhoea is likely during use of injectable contraceptives; this is more likely with DMPA than NET-EN, is more likely as time goes by, and is not harmful.
- C - Up to 50% of women stop using DMPA by 1 year; the most common reason for discontinuation is an altered bleeding pattern, including persistent bleeding.
Risks and Possible Side Effects
- C - DMPA use may be associated with an increase of up to 2-3 kg in weight over 1 year.
- C - DMPA use is not associated with acne, depression or headaches.
- B - DMPA use is associated with a small loss of bone mineral density, which is largely recovered when DMPA is discontinued.
- B - There is no evidence that DMPA use increases the risk of fracture.
Other Issues to Consider before Giving Injectable Contraceptives
Specific Groups, Medical Conditions and Contraindications
Because of the possible effect on bone mineral density, care should be taken in recommending DMPA to:
Healthcare professionals should be aware that:
- D(GPP) - Women with a body mass index over 30 can safely use DMPA and NET-EN
- C - Women who are breastfeeding can consider using injectable contraceptives.
Healthcare professionals should be aware that:
- D(GPP) - All progestogen only-methods, including injectable contraceptives, may be used by women who have migraine with or without aura
- D(GPP) - DMPA is medically safe for women to use if oestrogen is contraindicated
- D(GPP) - Injectable contraceptives are not contraindicated in women with diabetes
- D(GPP) - DMPA use may be associated with a reduction in the frequency of seizures in women with epilepsy
- D(GPP) - There is no evidence that DMPA use increases the risk of STI or HIV acquisition
- D(GPP) - DMPA is a safe and effective method of contraception for women with STIs, including HIV/AIDS (safer sex using condoms should be encouraged in this group)
- D(GPP) - Women taking liver enzyme-inducing medication may use DMPA and the dose interval does not need to be reduced.
Practical Details of Giving Injectable Contraceptives
D(GPP) - Injectable contraceptives should be given by deep intramuscular injection into the gluteal or deltoid muscle or the lateral thigh.
D(GPP) - Provided that it is reasonably certain that the woman is not pregnant, the use of injectable contraceptives may be started:
- Up to and including the fifth day of the menstrual cycle without the need for additional contraceptive protection
- At any other time in the menstrual cycle, but additional barrier contraception should be used for the first 7 days after the injection
- Immediately after first- or second-trimester abortion, or at any time thereafter
- At any time postpartum
Follow-Up and Managing Problems
D(GPP) - Women attending up to 2 weeks late for repeat injection of DMPA may be given the injection without the need for additional contraceptives.*
*Note: At the time of publication (October 2005), this use was outside the UK marketing authorisation. Check the Summary of Product Characteristics for current licensed indications. Informed consent is needed when using outside the licensed indications. This should be discussed and documented in the notes.
C - A pattern of persistent bleeding associated with DMPA use can be treated with mefenamic acid or ethinylestradiol.
D(GPP) - Women who wish to continue DMPA use beyond 2 years should have their individual clinical situations reviewed, the balance between the benefits and potential risks discussed, and be supported in their choice of whether or not to continue.**
**Note: Refer to Committee on Safety of Medicines advice issued in November 2004. Go to www.mhra.gov.uk and search for Depo Provera.
D(GPP) - Healthcare professionals should be aware that if pregnancy occurs during DMPA use there is no evidence of congenital malformation to the fetus.
Progestogen-Only Subdermal Implants (POSDIs)
Decision Making
Women should be given the following information.
Contraceptive Efficacy
- C - Implanon® acts by preventing ovulation.
- C - The pregnancy rate associated with the use of Implanon is very low (fewer than 1 in 1000 over 3 years).
- D - Implanon has UK Marketing Authorisation for use for 3 years.
- C - There is no evidence of a delay in the return of fertility following removal of contraceptive implants.
Effects on Periods
- C - Bleeding patterns are likely to change while using Implanon.
- C - 20% of women will have no bleeding, while almost 50% of women will have infrequent, frequent or prolonged bleeding.
- C - Bleeding patterns are likely to remain irregular over time.
- C - Dysmenorrhoea may be reduced during the use of Implanon.
Risks and Possible Side Effects
- C - Up to 43% of women stop using Implanon within 3 years; 33% of women stop because of irregular bleeding and less than 10% of women stop for other reasons including hormonal (non-bleeding) problems.
- C - Implanon use is not associated with changes in weight, mood, libido or headaches.
- C - Implanon use may be associated with acne.
Other Issues to Consider Before Fitting an Implant
Specific Groups, Medical Conditions and Contraindications
Healthcare professionals should be aware that:
- C - There is no evidence that the effectiveness or adverse effects of implants vary with the age of the user
- D(GPP) - Women over 70 kg can use Implanon as an effective method of contraception
- C - Contraceptive implants can safely be used by women who are breastfeeding.
Healthcare professionals should be aware that:
- D(GPP) - Implanon use is not contraindicated in women with diabetes
- D(GPP) - There is no evidence that implant use increases the risk of STI or HIV acquisition
- D(GPP) - Contraceptive implants are a safe and effective method of contraception for women with STI, including HIV/AIDS (safer sex using condoms should be encouraged in this group)
- D(GPP) - All progestogen-only methods, including contraceptive implants, may be used by women who have migraine with or without aura
- C - Contraceptive implants are medically safe for women to use if oestrogen is contraindicated
- C - There is no evidence of an effect of Implanon use on bone mineral density.
- D - Implanon is not recommended as a contraceptive method for women taking liver enzyme-inducing drugs.
Practical Details of Fitting Implants
D(GPP) - Provided that it is reasonably certain that the woman is not pregnant, Implanon may be inserted:
- At any time (but if the woman is amenorrhoeic or it has been more than 5 days since menstrual bleeding started, additional barrier contraception should be used for first 7 days after insertion)
- Immediately after abortion in any trimester
- At any time postpartum
Advice for Women at Time of Fitting
C - Women should be informed that Implanon insertion and removal both cause some discomfort and bruising but that technical problems are unusual (less than 1 in 100).
Follow-up and Managing Problems
D(GPP) - No routine follow-up is needed after implant insertion. However, a woman should be strongly encouraged to return at any time to discuss problems, if she wants to change her method of contraception, or if it is time to have the implant removed.
B - Irregular bleeding associated with implant use can be treated with mefenamic acid, ethinylestradiol.
D(GPP) - There is no evidence of a teratogenic effect of Implanon use but, if a woman becomes pregnant and continues with the pregnancy, the implant should be removed.
D(GPP) - If an Implanon implant cannot be palpated (due to deep insertion, failed insertion or migration) it should be localised by ultrasound investigation before being removed. Deeply inserted implants often need to be removed by an expert.
Definitions:
Levels of Evidence
1++: High-quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias
1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias
2++: High-quality systematic reviews of case-control or cohort studies; or high quality case-control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal
2+: Well-conducted case-control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that relationship is causal
2-: Case-control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal
3: Non-analytic studies (for example, case reports, case-series)
4: Expert opinion, formal consensus
Classification of Recommendations
A:
- At least one meta-analysis, systematic review, or randomised controlled trial (RCT) that is rated as 1++, and is directly applicable to the target population, or
- A systematic review of RCTs or a body of evidence that consists principally of studies rated as 1+, is directly applicable to the target population and demonstrates overall consistency of results, or
- Evidence drawn from a National Institute for Health and Clinical Excellence (NICE) technology appraisal
B:
- A body of evidence that includes studies rated as 2++, is directly applicable to the target population and demonstrates overall consistency of results or
- Extrapolated evidence from studies rated as 1++ or 1+
C:
- A body of evidence that includes studies rated as 2+, is directly applicable to the target population and demonstrates overall consistency of results, or
- Extrapolated evidence from studies rated as 2++
D:
- Evidence level 3 or 4, or
- Extrapolated evidence from studies rated as 2+, or
- Formal consensus
D(GPP): A good
- A good practice point (GPP) is a recommendation for best practice based on the experience of the Guideline Development Group
