Methotrexate and misoprostol vs misoprostol alone for early abortion. A randomized controlled trial
M. D. Creinin and E. Vittinghoff
Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco General Hospital.
OBJECTIVE--To compare the safety and efficacy of early abortion by
administration of methotrexate and misoprostol vs administration of
misoprostol alone. DESIGN--Randomized controlled trial. SETTING--San
Francisco (Calif) General Hospital. PATIENTS--Pregnant women at 56 days'
gestation or less seeking elective abortion. Sixty-three women volunteered
for the trial; 61 completed the study and are included in the analysis.
INTERVENTION--Intramuscular administration of 50 mg of methotrexate per
square meter of body surface area followed 3 days later by vaginal
administration of 800 micrograms of misoprostol (group 1) or the same dose
of misoprostol given alone (group 2). The misoprostol dose was repeated 24
hours later if abortion had not occurred. MAIN OUTCOME MEASURES--Successful
abortion, duration of vaginal bleeding, side effects, and change in
beta-human chorionic gonadotropin (beta-hCG) level. An abortion was
considered successful if the pregnancy ended without requiring a surgical
procedure. RESULTS--Complete abortion occurred in 28 (90%) of 31 patients
in group 1 and 14 (47%) of 30 patients in group 2 (P < .001). Seventeen
(61%) of the 28 women in group 1 who aborted did so the same day as
misoprostol administration; vaginal bleeding lasted a mean (+/- SD) of 10
(+/- 4) days, and beta-hCG level was less than or equal to 10 IU/L by a
mean of 31 (+/- 6) days after methotrexate administration. The 11 other
women in group 1 who aborted did so after a mean delay of 29 (+/- 11) days;
vaginal bleeding lasted 7 (+/- 4) days, and beta-hCG level was less than or
equal to 10 IU/L by a mean of 24 (+/- 11) days after the abortion. There
were three treatment failures in group 1: two ongoing pregnancies (6%) and
one incomplete abortion (3%). For the 14 women with successful abortions in
group 2, vaginal bleeding lasted a mean of 10 (+/- 6) days and beta-hCG
level was less than or equal to 10 IU/L by mean of 39 (+/- 18) days after
the misoprostol. There were 16 treatment failures in group 2: eight ongoing
pregnancies (27%), and eight incomplete abortions (27%). Methotrexate side
effects were minimal. Misoprostol side effects were diarrhea in 18% and
nausea and vomiting in 5%. CONCLUSIONS--Methotrexate and vaginal
misoprostol are more effective than misoprostol alone. Both drugs are
available throughout the United States, and both drugs are inexpensive.
This combination may offer an alternative to the use of antiprogestin and
prostaglandin for medical abortion.
A Randomized Comparison of Misoprostol 6 to 8 Hours Versus 24 Hours After Mifepristone for Abortion
Creinin et al.
Obstet Gynecol 2004;103:851-859.
ABSTRACT
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Misoprostol and Pregnancy
Goldberg et al.
NEJM 2001;344:38-47.
FULL TEXT
Vaginal misoprostol alone for medical abortion up to 9 weeks of gestation: efficacy and acceptability
Ngai et al.
Hum Reprod 2000;15:1159-1162.
ABSTRACT
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Medical Termination of Pregnancy
Christin-Maitre et al.
NEJM 2000;342:946-956.
FULL TEXT
A 26-Year-Old Woman Seeking an Abortion
Grimes
JAMA 1999;282:1169-1175.
FULL TEXT
JAMA, Abortion, and Editorial Responsibility
Lundberg
JAMA 1998;280:740-740.
FULL TEXT
Early Pregnancy Termination with Mifepristone and Misoprostol in the United States
Spitz et al.
NEJM 1998;338:1241-1247.
ABSTRACT
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Methotrexate and Misoprostol to Terminate Early Pregnancy
Hausknecht
NEJM 1995;333:537-540.
ABSTRACT
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