Objective: To test the feasibility of mounting a randomised controlled trial comparing mifepristone-misoprostol versus dilation and evacuation (D&E) for midtrimester abortion.
Design: Pilot randomised controlled trial.
Setting: University of North Carolina Hospitals, Chapel Hill, North Carolina.
Population: Women aged 18 years or older and without prior uterine operations who requested abortion at 14-19 menstrual weeks of gestation from January 2002 to January 2003.
Methods: Participants received either mifepristone 200 mg by mouth followed in two days by vaginal then oral misoprostol (Aberdeen regimen) or D&E after one or two days of laminaria preparation. Care was provided by residents under faculty supervision.
Main outcome measures: Enrolment rate and acceptability of and adverse events associated with methods.
Results: The trial was stopped at one year because of slow enrolment. Of 47 women eligible for the trial, 29 (62%) declined participation, primarily because of a preference for D&E abortion. Among the 18 participants enrolled, nine were randomised to treatment with mifepristone-misoprostol and 9 to D&E. Compared with D&E, mifepristone-misoprostol abortion caused more pain and adverse events, although none was serious.
Conclusions: Our findings concerning acceptability and adverse events should be considered hypothesis-generating; they may prove useful in planning a larger randomised controlled trial. Such a trial will be difficult to mount in the US. Hence, we suggest that it be done in a setting where labour-induction abortion is the norm.