PUBLIC HEARINGS CONVENED BY THE PORTFOLIO COMMITTEE ON HEALTH IN THE CHOICE ON TERMINATION OF PREGNANCY ACT, 1996

MEDICAL RESEARCH COUNCIL

Submission presented by Dr Rachel Jewkes, Director, Women's Health Research Unit

Introduction

Over the last three years Medical Research Council researchers have been working with colleagues from the Reproductive Health Research Unit to investigate the use and misuse of misoprostol in termination of pregnancy. The research has investigated the appropriate use of misoprostol through a clinical trial designed to enable description of the benefits of using misoprostol for cervical ripening prior to first trimester termination of pregnancy with manual vacuum aspiration. We are also in the process of collecting data which will help to describe the misuse of misoprostol in procurement of abortions outside the terms of the Act, as part of a study which seeks to understand why women are still having illegal abortions in Gauteng and how this is being done. The findings of these studies will be presented and their implications for the implementation of the Act will be discussed.

Misoprostol in clinical management of first trimester terminations

Background

The need to clarify several aspects of the use of misoprostol for cervical ripening prior to first trimester terminations became evident after review of the literature and discussions with South African clinicians. These indicated a widespread belief in effectiveness which was not adequately supported by scientific evidence. We found that misoprostol was being used in a wide variety of combinations of dose and route of administration. There was particular uncertainty about whether the drug should be given 12 hours before the operation (in practice the night before) or could just be given on the morning of the procedure. Some hospitals were admitting patients overnight so that they could be given the drug, others were giving patients tablets to take at home the night before, but others still were just giving a dose on the morning of the operation.

Methods

We therefore planned a study using a randomised controlled trial methodology, which is the most scientifically rigorous way of testing effectiveness. The aim was to see whether misoprostol was really effective in softening the cervix when given between 2-4 hours before the operation and whether its use made the procedure quicker, easier and safer. The study was done in Kalafong Hospital, with 270 patients. They were all in the first trimester. Half of these were given 600g misoprostol and told to insert it into their vagina themselves, the other half were given vitamin C tablets, which are known to have no effect on the uterus and therefore to be a placebo. Patients and medical staff did not know which type of tablet they received. The study has been published in the South African Medical Journal (de Jonge et al, 2000).

Results

All the patients managed to insert the tablets themselves.

- In the misoprostol group, in over two-thirds (69%) the cervix had dilated sufficiently for the operation to be performed without any further dilatation.

In the placebo group, it was sufficiently dilated in just over a third (38%) of women. The reason why it was as high as this in the placebo group is that the pregnant cervix, in most women, is quite soft and will dilate a little as soon as an instrument is pushed against it. In the misoprostol group, the operation took on average 3.7 minutes

- In the placebo group, the average time was 5.4 minutes.

- In the misoprostol group, in 82% of cases the staff reported the operation to be "easy"

- In the placebo group, only 63% described it as "easy".

- Side-effects were mild, patients with misoprostol experienced some cramps before the operation and two-thirds reported pain to be mild or absent during operation. Severe or very severe pain was reported by 16%. There was less pain in the placebo group.

- In the misoprostol group, 5% of women could not have the manual vacuum aspiration as the cervix could not be dilated

- In the placebo group, this problem was encountered in 15% of cases.

Conclusions

This study has shown that misoprostol is an important drug in the management of women requesting first trimester terminations of pregnancy. Its use enhances the ease and, therefore, safety of the procedure and reduces the cost through reducing treatment failures and shortening operation time. It is highly effective administered two hours pre-operatively. Most of the problems with misoprostol use relate to its administration outside a controlled clinical setting, or the additional cost of admitting patients the night before the procedure so they can be given the drug. Our findings demonstrate that the additional risks or costs of these practices can not be medically justified. In the study the patients inserted their own tablets and this has been effective. This practice takes the responsibility for actually initiating the abortion from health workers, which enhances acceptability of involvement in the procedure.

Misoprostol in illegal abortions

Introduction and methods

There is abundant anecdotal evidence that misoprostol and other methods are being used to initiate illegal abortions in the community. In order to gain an understanding of why women are still aborting on the back street and how they are doing this we have initiated a sudy tnterviewing women attending hospitals in Gauteng with incomplete abortions. The study is still in progress but we present preliminary findings based on nine cases from Baragwanath Hospital.

Findings

- The women were aged between 21-43 years, all lived in Soweto and they had between 0-9 children. Several had had previous backstreet abortions. Most were between 16-20 weeks pregnant.

- The methods used included: taking traditional medicines, Dutch medicines, oral contraceptives, other medicines e.g. laxatives, pain killers, inserting wooden sticks in the cervix and taking misoprostol.

- Most self-induced or had help from their husband, traditional healers were also involved as were medical and nursing staff.

- There were two examples of medical involvement, one was a GP who charged R300 for some misoprostol tablets and the other was a "clinic" which was run by nurses where women were given four tablets of misoprostol and told to return after three days. The charge was R250. One patient using this became very severely infected and had to go to Bara for the evacuation.

- Most women knew something about the law but lacked specific information about up to how many weeks they could legally terminate, that termination was available on request or where to go.

- Several did not use legal services because they were told lists were full, they were asked why they wanted to "kill their baby" and accused of being a "murderer", or because they feared being shouted at.

Conclusions:

Even in Gauteng, where there are many legal services, many women are still using traditional backstreet abortion methods. In some cases these services are provided for profit by GPs and nurses and misoprostol is being used. Contributing to the backstreet industry is a lack of specific knowledge in communities about the law, how to access services and the need to take action early in pregnancy. Clearly more public education is needed. A second major factor is shortage of facilities for second trimester abortions, and experiences of or fear of abuse by hospital staff.

Misoprostol is a very useful and safe drug if used properly, however like most drugs it is dangerous if abused. The two examples of health workers prescribing misoprostol found here represent naked profiteering, particularly as Gauteng has more services than other areas. The Health Professions Council and Nursing Council need to remind registered staff that participating in abortions undertaken outside the terms of the Act is illegal. Efforts are needed to enable GPs who are keen to provide abortion services to become trained and have their premises designated for this purpose. Efforts are needed to protect patients from abuse by staff in health facilities and to take action against staff who infringe patients' rights.

REFERENCES

de Jonge E, Jewkes R, Levin J, Rees H. RCT of the efficacy of misoprostol as a cervical ripening agent prior to first trimester TOP. South African Medical Journal 2000; 90:256-262.