SC Robson,^1* T Kelly,¹ D Howel,^1,3 M Deverill,² J Hewison,⁴ MLS Lie,² E Stamp,² N Armstrong² and CR May²

¹Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK
²Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK
³School of Mathematics and Statistics, Newcastle University, Newcastle upon Tyne, UK
⁴Leeds Institute of Health Sciences, University of Leeds, Leeds, UK

^*Corresponding author

Objectives

To determine the acceptability, efficacy and costs of medical termination of pregnancy (MTOP) compared with surgical termination of pregnancy (STOP) at less than 14 weeks' gestation, and to understand women's decision-making processes and experiences when accessing the termination service and taking part in the trial.

Design

A partially randomised preference trial and economic evaluation with follow-up at 2 weeks and 3 months.

Setting

The Royal Victoria Infirmary, Newcastle upon Tyne, UK, a large tertiary unit providing both MTOP and STOP up to 20 weeks' gestation to women throughout the north-east of England. The termination service is nurse practitioner-led and undertakes around 1800 terminations per year.

Participants

Participants were women accepted for termination of pregnancy (TOP) under clause C of the Human Fertilisation and Embryology Act (1990) amendment of the Abortion Act (1967) with pregnancies less than 14 weeks' gestation (based on ultrasound) on the day of abortion. A further group of women attending contraception and sexual health clinics in Newcastle upon Tyne participated in a discrete choice experiment.

Interventions

Surgical termination of pregnancy

All women ≥ 6 weeks' and < 14 weeks' gestation were primed with misoprostol 400 µg 2 hours prior to the procedure. All STOP procedures were performed under general anaesthesia using vacuum aspiration (VA) by two consultants each on a dedicated operating list.

Medical termination of pregnancy

All women < 14 weeks' gestation were given mifepristone 200 mg orally. They returned 36–48 hours later to the gynaecological day-case ward for prostaglandins (detailed below).

• Women ≤ 9 weeks' gestation were given misoprostol 800 µg vaginally, followed 4 hours later by misoprostol 400 µg if no abortion had occurred. Subsequently if abortion did not occur by 1630–1700 and there was no excessive bleeding, women were discharged home with 2-week follow-up scan review.
• Women ≥ 9+1 weeks' gestation were given misoprostol 800 µg vaginally followed by misoprostol 400 µg every 3 hours up to a maximum of four doses. If by midnight no abortion had occurred, mifepristone 200 mg orally was administered followed by gemeprost 1 mg vaginally 3-hourly from 0800 up to a maximum of five doses. If abortion had not occurred by 0800 the following morning, STOP was arranged.

Main outcome measures

The main outcome measure was acceptability determined by responses to the question: 'If you ever have another termination of pregnancy, would you opt for the same method?'

Secondary outcome measures included strength of preference by willingness to pay (WTP) using the payment card method; distress using the Impact of Event Scale (IES); anxiety and depression using the Hospital Anxiety and Depression Scale (HADS); satisfaction with care using a 5-point Likert scale; experience of care using a semantic differential rating scale; frequency and extent of symptoms including self-assessment of pain using a visual analogue scale; clinical effectiveness using unplanned/emergency admission requiring an overnight stay and complications.

A discrete choice experiment was used to identify key factors (attributes) that shape women's preferences for abortion services.

Results

The trial recruited 1877 women: 349 in the randomised arms and 1528 in the preference arms. Of those in the preference arms, 54% chose MTOP. When questioned 2 weeks after the procedure more women having STOP would choose the same method again in the future {adjusted difference 24.9% [95% confidence interval (CI) 15.8 to 34.9%] in the randomised arm and 15.9% [95% CI 12.2 to 19.6%] in the preference arm}. Acceptability of MTOP declined with increasing gestational age. The difference in acceptability between STOP and MTOP persisted at 3 months.

There was no difference in the maximum amount women were willing to pay for their preferred method prior to the procedure. At 2 weeks after TOP, women in the preference arms were prepared to pay more to have their preferred option, but there was no difference in the mean maximum WTP values between MTOP and STOP in the randomised or preference arms.

There were no differences in anxiety or depression between women having MTOP and STOP as measured by HADS. However, women randomised to MTOP had higher scores on the intrusion subscale of the IES at 2 weeks and both the intrusion and avoidance subscales at 3 months. There was no difference in IES scores between the MTOP and STOP groups in the preference arms.

Women were more likely to be satisfied overall and with the technical and interpersonal aspects of care if they had STOP rather than MTOP whether in the preference arms or randomised arms.

Experience of care as determined by median semantic differential scores were lower after MTOP in both randomised and preference groups. MTOP was felt to be more unpleasant, more disagreeable, harder and more painful while STOP was felt to be milder, more agreeable, faster and safer.

During admission women undergoing MTOP had more symptoms and reported higher mean pain scores. Compared with women having STOP, more women having MTOP reported nausea and diarrhoea after discharge. There were no differences in time taken to return to work between groups; around 90% of women had returned to work and normal activity by 2 weeks.

Rates of unplanned or emergency admissions were higher after MTOP than STOP (4.2% versus 0.7% respectively). Overall complication rates were also higher after MTOP (5.0% versus 2.6% respectively), although this difference only achieved statistical significance in the preference arm.

The overall cost of STOP was greater than MTOP (£498 versus £287 respectively) due to higher inpatient standard costs. Even though complication rates were higher with MTOP, the medical procedure was more cost-effective based on the measure of effectiveness used (successful completion of TOP on the day of admission).

A discrete choice experiment identified three service attributes that had an almost equal impact on women's preferences: the provision of counselling, the number of days delay to the procedure and the possibility of the need for an overnight stay. Women would be prepared to wait approximately one extra day to ensure access to post-termination counselling and to avoid an overnight stay following a termination.

Qualitative substudy

Women wanted quick access to abortion, but were concerned about what professionals thought of them. Women also found accessing the service via family planning clinics easier than via general practitioner surgeries. Once in the hospital service, quick assessment and treatment was important to them.

Women participated in the trial because by helping others they were able to feel compensated in some way for the unpleasant experience of undergoing termination. Some felt a general ethical obligation to help while others gained different levels of personal benefit; some women found talking about their experiences cathartic.

Some women found the concept of letting the computer 'choose' difficult to understand. For those with a strong pre-existing preference the trial design meant that women could still benefit by both choosing which method they preferred and participate in the trial to help others.

Conclusions

MTOP was associated with more negative experiences of care and lower acceptability. Acceptability of MTOP declined with increasing gestational age. MTOP was less costly, but also less effective than STOP. Women value the option to choose their preferred abortion method. However, the majority of women choosing MTOP were satisfied with their care and found the procedure acceptable, suggesting that a patient-centred abortion service should offer the choice of medical or surgical abortion up to 14 weeks of pregnancy.

Recommendations for further research

An audit of provision of MTOP and STOP in England and Wales is urgently required. Further studies exploring the barriers to offering women the choice of method of TOP are needed, together with research on the acceptability and effectiveness of (1) MTOP and manual VA in pregnancies below 9 weeks' gestation and (2) MTOP and dilatation and evacuation after 14 weeks' gestation.

Trial registration

This trial is registered as ISRCTN07823656.

Publication

Robson SC, Kelly T, Howel D, Deverill M, Hewison J, Lie MLS, et al. Randomised preference trial of medical versus surgical termination of pregnancy less than 14 weeks' gestation (TOPS). Health Technol Assess 2009;13(53).

NIHR Health Technology Assessment programme

The Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care.

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