Mifepristone and misoprostol versus dilation and evacuation for midtrimester abortion: a pilot randomised controlled trial.
OBJECTIVE
To test the feasibility of mounting a randomised controlled trial comparing mifepristone-misoprostol versus dilation and evacuation (D&E) for midtrimester abortion.


METHODS
Pilot randomised controlled trial.


METHODS
University of North Carolina Hospitals, Chapel Hill, North Carolina.


METHODS
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.


METHODS
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.
Grimes
David A
DA
Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
Smith
M Susan
MS
Witham
Angela D
AD
D000019:Abortifacient Agents; D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage* / Q000009:adverse effects; D000021:Abortifacient Agents, Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D000028:Abortion, Induced / Q000379:methods*; D000282:Administration, Intravaginal; D000284:Administration, Oral; D000328:Adult; D004107:Dilatation and Curettage; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D015735:Mifepristone / Q000008:administration & dosage* / Q000009:adverse effects; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects; D017060:Patient Satisfaction; D010865:Pilot Projects; D011247:Pregnancy; D011262:Pregnancy Trimester, Second; D016896:Treatment Outcome
D000019:Abortifacient Agents; D000020:Abortifacient Agents, Nonsteroidal; D000021:Abortifacient Agents, Steroidal; D016595:Misoprostol; D015735:Mifepristone