The efficacy and tolerance of mifepristone and prostaglandin in first trimester termination of pregnancy. UK Multicentre Trial

Abstract

Objective: To investigate the use of oral mifepristone (RU 486) and vaginal gemeprost for the induction of legal first trimester abortion.

Design: An uncontrolled multicentre observational study.

Setting: 13 Hospital gynaecological units in Scotland and England.

Subjects: 588 Pregnant women with up to nine weeks amenorrhoea having legal abortions.

Interventions: Oral mifepristone 600 mg followed 48 h later by vaginal gemeprost 1 mg. Women stayed in the hospital for a minimum of 4 h on each occasion.

Main outcome measures: Frequency of complete abortion and the need for subsequent surgical evacuation, analgesia and blood transfusion.

Results: There was complete abortion in 94% (95% CI 92-96%). None of the 46 women at less than 43 days gestation needed surgical evacuation. This was performed in 6.5% of the remainder but among these the rate did not increase with gestation. Five women (four from one centre) required both curettage and blood transfusion. A fall in haemoglobin concentration of 2-4 g/dl occurred in only 1%. Narcotic analgesia was required after gemeprost by 37% of nullipara and 13% of multipara. Overall 26% had vomiting and 13% diarrhoea.

Conclusion: The sequential use of oral mifepristone and vaginal gemeprost is effective in inducing abortion up to the 63rd day of pregnancy. Efficient management of pain and bleeding is easier if women are in a hospital for some hours after the gemeprost.