Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial.
OBJECTIVE
To study the efficacy, safety, and acceptability of oral immediately swallowed and buccal misoprostol 800 mcg after mifepristone 200 mg for terminating pregnancy through 63 days since the last menstrual period (LMP).


METHODS
This seven-site study randomly assigned 966 women seeking abortions to oral or buccal misoprostol 800 mcg 24-36 hours after mifepristone 200 mg with 7-14-day follow-up.


RESULTS
Success rates in the oral and buccal groups were 91.3% (389 of 426) and 96.2% (405 of 421), respectively (P=.003; relative risk [RR] 0.95, 95% confidence interval [CI] 0.92-0.98). Ongoing pregnancy occurred in 3.5% (15 of 426) of women who took oral misoprostol compared with 1.0% (4 of 421) of women in the buccal group (P=.012; RR 3.71, 95% CI 1.24-11.07). Through 49 days since the LMP, oral and buccal regimens performed similarly, but success with oral misoprostol decreased as pregnancy advanced. In pregnancies of 57-63 days since the LMP, success with oral misoprostol fell below 90%, whereas that with buccal remained high (oral 85.1% [97 of 114], buccal 94.8% [109 of 115], P=.015, RR 0.90, 95% CI 0.82-0.98). Furthermore, in this gestational age group, there were significantly more ongoing pregnancies among women who took misoprostol orally (7.9% [9 of 114]) compared with buccally (1.7% [2 of 115]; P=.029, RR 4.54, 95% CI 1.0-20.55). Adverse effect profiles were similar, although fever and chills were reported approximately 10% more often among women who took buccal misoprostol. Satisfaction and acceptability were high for both methods.


CONCLUSIONS
Buccal misoprostol 800 mcg after mifepristone 200 mg is a good option for medical abortion through 63 days since the LMP. Oral misoprostol 800 mcg is also a safe and effective alternative, although success rates diminish with increasing gestational age.


BACKGROUND
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00386867


METHODS
I.
Winikoff
Beverly
B
From the Gynuity Health Projects, New York, New York; Magee Womens Hospital/University of Pittsburgh, Pittsburgh, Pennsylvania; Planned Parenthood of Waco, Waco, Texas; Planned Parenthood League of Massachusetts, Boston, Massachusetts; Whole Woman's Health, Austin, Texas; Family Planning Associates Medical Group, Chicago, Illinois; Parkmed, New York, New York; and Institute for Urban Family Health, New York, New York.
Dzuba
Ilana G
IG
Creinin
Mitchell D
MD
Crowden
William A
WA
Goldberg
Alisa B
AB
Gonzales
Juliana
J
Howe
Michelle
M
Moskowitz
Jeffrey
J
Prine
Linda
L
Shannon
Caitlin S
CS
D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage*; D000021:Abortifacient Agents, Steroidal / Q000008:administration & dosage*; D000028:Abortion, Induced / Q000379:methods*; D000278:Administration, Buccal; D000284:Administration, Oral; D004359:Drug Therapy, Combination; D005260:Female; D005865:Gestational Age; D006801:Humans; D015735:Mifepristone / Q000008:administration & dosage*; D016595:Misoprostol / Q000008:administration & dosage*; D011247:Pregnancy; D016896:Treatment Outcome; D055815:Young Adult
D000020:Abortifacient Agents, Nonsteroidal; D000021:Abortifacient Agents, Steroidal; D016595:Misoprostol; D015735:Mifepristone