26 January 2011
UK: New RCOG guidance highlights advances in abortion care
Britain’s Royal Society of Obstetricians and Gynaecologists (RCOG) on 22 January published, for consultation, its draft evidence-based clinical guideline, The Care of Women Requesting Induced Abortion.
This will replace the guidance produced in 2000, and last updated in 2004. It is a thorough and comprehensive document, running to 86 pages, providing important summaries of scientific evidence and recommendations based on best practice. Some key points are summarised here.
The extent and practice of abortion
The RCOG first notes (1.1) that ‘Induced abortion is common; over 200,000 procedures are performed each year in Great Britain and at least one third of British women will have had an abortion by the time they reach the age of 45 years.’ The extent of women’s need for abortion motivates the development of guidance for best practice in this area.
This new document reiterates the recommendation of the RCOG Working Party on Unplanned Pregnancy (1991) ‘health authorities should accept responsibility for the abortions needed by women resident in their districts’, and notes the high proportion of abortions funded by the NHS but carried out in the independent sector. Thus the clinical management of women requesting abortion spans a number of care sectors involving a range of professionals and the guidelines are written with this in mind.’
The guidance further notes that ‘the proportion of procedures performed in England and Wales under 10 weeks has increased to 75%’, which reflects an improvement in access. However, local variation in access remains, and there are some ongoing problems with access to abortion in later gestations that should be addressed.
The relationship between law and clinical practice
Section 1.1 notes the RCOG’s contribution, in 2007, to the House of Commons Science and Technology Committee’s inquiry into recent scientific developments relating to the Abortion Act 1967. The STC’s report highlighted a number of issues for members of parliament to consider, including:
• the case for removing the need for two doctors’ signatures authorising the abortion
• recommendations allowing greater responsibility for nurses already involved in service provision
• the recommendation that there were no reasons of safety, efficacy or acceptability for not allowing women to have the second stage of medical abortion at home.
The 2011 guidance notes that ‘Although the House of Commons chose not to amend the law relating to induced abortion in any of the above respects, the RCOG would still support these changes should any change in the regulations allow them to take place.’ It provides detailed evidence, drawn from scientific studies and clinical practice, supporting the safety, efficacy and acceptability of ‘home use’ of misoprostol: the second stage of medical abortion.
Early medical abortion (up to 63 days’ gestation)
The guidance (2.4) notes that ‘Medical abortion using mifepristone and a prostaglandin is effective and appropriate at any gestation.’ For Early Medical Abotion, the following regimens are recommended:
• Mifepristone 200 mg orally followed 24–48 hours later by misoprostol 800μg given by the vaginal, buccal or sublingual route. Vaginal misoprostol may be administered by a clinician or self-administered by the woman.
• For gestational ages up to 49 days, 200 mg oral mifepristone followed 24–48 hours later by 400μg of oral misoprostol may be used.
• For women at 50–63 days of gestation, if abortion has not occurred 4 hours after administration of misoprostol, a second dose of misoprostol 400μg may be administered vaginally or orally (depending upon preference and amount of bleeding).
Specifically regarding the ‘place of misoprostol administration’, Recommendation 86 of the new guidance states:
‘It is safe and acceptable for women who wish to leave the abortion unit following misoprostol administration to complete the abortion at home. There must be an adequate support strategy and robust follow up arrangements for these women.’
Evidence supporting this recommendation is discussed on pages 71-2 of the draft guidance. The RCOG explains: ‘In England, according to the DH’s [Department of Health’s] interpretation of the Abortion Act, both mifepristone and misoprostol must be given in premises licensed for abortion although there is no legal restriction on where the abortion actually takes place. Several studies have confirmed that home use of misoprostol is safe, acceptable and effective to 63 days’ gestation and in many other countries it is the standard of care.’
The RCOG concludes, based on the evidence about home use of misoprostol: ‘It is clear that women who are able to choose their method of abortion are more satisfied with the outcome, than women denied a choice. Neither early medical abortion nor home administration of misoprostol suits all women. However, published data do not suggest any clinical reason why women should remain in hospital during their abortion, and demonstrate that it is safe for women to administer misoprostol at home.’
In a situation where legal restrictions prevent home use of misoprostol, the RCOG’s Recommendation 28 is that ‘Services should have a protocol in place allowing early discharge after misoprostol for women undergoing medical abortion up to 9 weeks of gestation’. Such protocols, which are already used by most providers, allow women ‘to spend less time in hospital thus maintaining their privacy and reducing disruption to their family’. The guidance further notes that ‘Since the first edition of this guideline (2000), the published literature on safety, efficacy and acceptability of taking the misoprostol at home has grown … While taking misoprostol at home is not legal in Great Britain the evidence would support its use were that to be possible at some time in the future.’
Later medical abortion
Section 2.4 notes that ‘For medical abortion using the following regimen is a safe, effective and acceptable alternative to surgical abortion for women between 9 and 13 weeks of gestation: mifepristone 200 mg orally followed 36–48 hours later by misoprostol 800μg vaginally followed by repeated doses of misoprostol 400 μg orally or vaginally at 3-hourly intervals.’
For abortion from 13 to 24 weeks’ gestation, the RCOG gives the following regimen as optimal: Mifepristone 200 mg orally, followed 36–48 hours later by misoprostol 800μg vaginally, then misoprostol 400 μg orally or vaginally, 3-hourly, to a maximum of four doses. The guidance notes that ‘If abortion does not occur mifepristone can be repeated 3 hours after the last dose of misoprostol and 12 hours later misoprostol may be recommenced.’ Surgical evacuation of the uterus is ‘not required routinely’ following medical abortion at this gestation, and should only be undertaken ‘if there is clinical evidence that the abortion is incomplete’.
The guidance (2.4) states that ‘vacuum aspiration is an appropriate method of surgical abortion at gestations up to 13 weeks.’ Both electric or manual vacuum aspiration ‘are effective and acceptable to women and clinicians’. Vacuum aspiration under 7 weeks’ gestation ‘should be performed with appropriate safeguards to ensure complete abortion including inspection of aspirated tissue, followed by ultrasound and serial serum hCG determination if indicated’.
Vacuum aspiration may be performed over 13 weeks’ gestation ‘using larger bore cannula and suction tubing, however as forceps are often required to remove larger fetal parts, use of this method must be determined by the skills and resources of the operating surgeon’.
The guidance states that surgical abortion by D&E, preceded by cervical preparation, ‘is appropriate for pregnancies above 13 weeks of gestation’. The RCOG recommends continuous ultrasound guidance during this procedure and the consideration of cervical preparation.
Complications and sequelae
The 2011 guidance (2.2) states that ‘Women should be advised that abortion is generally safer than continuing a pregnancy to term.’ While stressing that information should ‘emphasise the overall safety of the procedure’, the guidance lists the complications and sequelae that should be discussed with women.
Regarding the scare stories often promoted in relation to abortion, the guidance makes the following clear statements, backed up later in the guidance by a review of the evidence:
• Women should be informed that induced abortion is not associated with an increase in breast cancer.
• Women should be informed that there are no proven associations between induced abortion and subsequent ectopic pregnancy, placenta praevia or infertility.
• Women should be informed that induced abortion is associated with a small increase in risk of subsequent preterm birth, which increases with the number of abortions.
• Women should be informed that most women who have abortions do not experience adverse psychological sequelae.
The guidance goes on to note that ‘the most rigorous studies support the view that any observed associations between abortion and mental health problems do not appear to be related to abortion itself but to pre-existing conditions and co-occurring risk factors. Although abortion can be associated with a range of feelings, long term feelings of sadness, guilt and regret appear to linger in only a minority of women.’ The RCOG’s Recommendation 46, therefore, is that ‘Women who are certain of their decision to have an abortion should not be subjected to compulsory counselling’.
The guidance also notes that women should be informed that there is a ‘small risk’ of failure to end the pregnancy or incomplete abortion. They should also be informed that ‘infection of varying degrees of severity may occur after medical or surgical abortion’: this is usually caused by pre-existing infection, and the risk is reduced by prophylactic antibiotic use and bacterial screening for lower genital tract infection. The RCOG recommends antibiotic prophylaxis for both medical and surgical abortion.
The guidance also lists the following rare but serious complications:
• Uterine rupture has been reported in association with medical abortion. The risk is less than 1 in a 1000.
• Severe bleeding requiring transfusion; the risk is lower for early abortions occurring in less than 1 in 1000 rising to around 4 in 1000 at gestations beyond 20 weeks
• Uterine perforation (surgical abortion only); the risk is in the order of 1–4 per 1000 and is lower for early abortions and those performed by experienced clinicians
• Cervical trauma (surgical abortion only): the risk of damage to the external os is no greater than 1 in 100 and is lower for early abortions and those performed by experienced clinicians.
Anaesthesia and analgesia
For medical abortion, the guidance (2.4) states that ‘All women should be routinely offered pain relief (e.g. NSAIDs) during medical abortion. Oral paracetamol is not recommended, as it ‘has not been shown to reduce pain more than placebo’; and ‘some women may require additional narcotic analgesia, particularly after 13 weeks of gestation’.
For surgical abortion, the guidance similarly recommends NSAIDs rather than paracetamol. It recommends that services ‘should be able to provide surgical abortions without resort to general anaesthesia’, suggesting that local anaesthesia should be provided as well. It further states: ‘If conscious sedation is used during surgical abortion, it should be undertaken only by trained practitioners and in line with DH guidance.’
Scanning and follow-up
The guidance (2.3) notes that ‘ultrasound scanning must be available to all services as it may be required as part of the assessment’: however, it states that ‘Use of routine pre-abortion ultrasound scanning is unnecessary’, as there is ‘no direct evidence that routine ultrasound improves either the safety or efficacy of abortion procedures’. The guidance further notes that ‘medical abortion is provided safely in resource poor settings which do not have access to routine ultrasound’, and that ‘the insistence of the need for routine pre-abortion ultrasound limits the settings in which abortion can be offered in Great Britain’.
When provided, ultrasound scanning should be ‘in a setting and manner sensitive to the woman’s situation’, and ‘women should be offered the opportunity to see the ultrasound image but should only be shown it if they so wish’.
In relation to follow-up, section 2.5 states that ‘there is no medical need for routine follow-up after surgical abortion or after medical abortion if successful abortion has been confirmed at the time of the procedure’. Women having a medical abortion ‘in whom successful abortion has not been confirmed at the time of the procedure should be offered follow-up to exclude ongoing pregnancy’, and all women ‘should be able to choose to return for routine follow-up if they so wish’.
In discussing the evidence supporting this recommendation, the guideline states that ‘further research is required to determine if a combination of pregnancy testing at home and questions about pregnancy symptoms/signs could be used to screen for ongoing pregnancy after medical abortion and identify those women who require a clinic follow-up’.
In the ‘absence of evidence to recommend a particular process for routine follow-up to exclude ongoing pregnancy after medical abortion’, the RCOG recommends that ‘services should agree a protocol for local use taking into consideration the length of time an individual women stays in the abortion service after misoprostol, her risk factors for failure and the distance she would have to travel to attend follow-up. It may be considered appropriate for the majority of women to be contacted by telephone to ask about post-procedure bleeding and symptoms together with a carefully performed urine pregnancy test or serum hCG determination.’
The guidance further recommends that ‘ultrasound examination should not be used routinely to screen women for incomplete abortion’, and that the decision to evacuate the uterus ‘should be based on clinical signs and symptoms and not on ultrasound appearances’.
Contraception after abortion
The guidance (2.5) states that ‘Abortion services should be able to provide all methods of contraception … immediately after abortion’, and that ‘women should be advised of the greater effectiveness of long acting reversible methods of contraception (LARC)’. Women who choose not to start a contraceptive method immediately ‘should be given information about local contraceptive providers in addition to their general practitioner’.
The guidance notes that ‘intrauterine contraceptives ‘can be inserted immediately following a medical and surgical abortion at all gestations as long as it is reasonably certain that the woman is not still pregnant.’ Although ‘sterilisation can be safely performed at the time of induced abortion’, it may be more likely to be associated with regret.
Choice and referral
The RCOG recommends (4.5) that ‘All services should be able to offer a choice of recommended methods for each gestation band’, and notes that ‘Medical and surgical methods of abortion differ in respect of the procedure duration, number of required visits, effectiveness, side effects, and complication profile. In most studies, women expressed similar levels of satisfaction regardless of which abortion procedure was used’.
The guidance (2.1) also notes that ‘a system should be in place to ensure that doctors within the abortion service complete form HSA1 if a woman refers herself, or if the referring doctor is not willing to support the abortion’; that ‘services should be commissioned for all women requesting induced abortion at all gestations’, and that ‘women should be informed that they have a right to delay appointments and/or the procedure should they wish’.
Acknowledging the ‘substantial role’ that nurses play in the provision of abortion services, the 2011 guidance (1.1) ‘recognises the lack of a formal training programme for this role’ and recommends that ‘the RCN [Royal College of Nursing] gives thought to developing and implementing specialist training programmes for nurses working in abortion care.’
In its discussion of D&E, the guidance highlights a discrepancy between NHS abortion services, where ‘few surgeons perform D&E’, and the independent sector, where this ‘is the commonest method used at gestations above 13 weeks’. The guidance states that ‘D&E can be undertaken safely by providers who have been trained in the technique, have the necessary instruments and a caseload sufficient to maintain their skills. For those lacking the necessary expertise and caseload medical abortion using mifepristone and a prostaglandin is appropriate.’
Consent, confidentiality and conscientious objection
The guidance also reviews the law and best practice surrounding consent and confidentiality, including the determination of Fraser competence. Its Recommendation 7, in line with the law on the right to conscientious objection, is that ‘Professionals who are ethically opposed to abortion have a duty of care to refer onward in a timely manner women requesting abortion’. The guidance affirms (section 3.9) that ‘The decision to have an abortion rests with the woman and her doctors.’
The draft guidance, The Care of Women Requesting Induced Abortion (January 2011), is published here.
New abortion guidance shows home-use of medication is safe, as anti-abortion group joins High Court action. BPAS press release, 27 January 2011