Human Reproduction, Vol. 19, No. 2, 266-271,
February 2004
© 2004 European Society of Human Reproduction and Embryology
A randomized controlled trial comparing medical and expectant management of first trimester miscarriage
1 Department of Obstetrics and Gynaecology, Nelson R.Mandela School of Medicine, University of Natal, Durban, South Africa, 2 Department of Reproductive Science and Medicine, Imperial College and St Mary’s Hospital, London, UK and 3 Medical Research Council, Durban, South Africa
4 To whom correspondence should be addressed at: Department of Obstetrics and Gynaecology, Nelson R.Mandela School of Medicine, Private Bag 7, Congella, 4013, South Africa. e-mail: bagrateej1{at}nu.ac.za
BACKGROUND: We aimed to determine whether outpatient treatment of miscarriage with vaginal misoprostol is more effective than expectant management in reducing the need for surgical evacuation of retained products of conception (ERPC). METHODS: Of 131 eligible women with first trimester miscarriage, 104 agreed to randomization to either 600 µg misoprostol or placebo intravaginally. They were assessed the following day and administered a second dose of their allocated treatment if miscarriage was not complete. Those not successful after two doses were seen on day 7, and, if miscarriage was not complete, an ERPC was performed. RESULTS: The success rate of medical management was 88.5% (46/52) compared with 44.2% (23/52) for expectant management. There was no significant difference in success rate (100 versus 85.7%) in women treated with an incomplete miscarriage. Women with early pregnancy failure had a success rate of 87% with misoprostol compared with 29% with expectant management [odds ratio (OR) 15.96; 95% confidence interval (CI) 5.26, 48.37]. The complete miscarriage rate was achieved quicker in the medical group than the expectant group by day 1 (32.7 versus 5.8%) and by day 2 (73.1 versus 13.5%) of treatment. There were no differences in side-effects, bleeding duration, analgesia use, pain score and satisfaction with treatment. Women in the expectant group made more outpatient visits (5.06 versus 4.44%; OR = –0.62, 95% CI –1.04, –0.19). More women in the medical group (90.4 versus 73.1%; OR 1.26, 95% CI 1.05, 1.50) would elect the same treatment in the future. CONCLUSIONS: Medical management using 600 µg misoprostol vaginally is more effective than expectant management of early pregnancy failure. Misoprostol did not increase the side-effect profile and patient acceptability was superior to expectant management.
Key words: early pregnancy failure/expectant management/first trimester miscarriage/medical management/vaginal misoprostol
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