Pl. Giacalone et al., CERVICAL RIPENING WITH MIFEPRISTONE BEFORE LABOR INDUCTION - A RANDOMIZED STUDY, Obstetrics and gynecology, 92(4), 1998, pp. 487-492
Objective: To determine the efficacy and safety of mifepristone for ce
rvical ripening in post-term pregnancies. Methods: Women with post-ter
m pregnancies and Bishop scores less than 6 were assigned randomly to
mifepristone (41 patients) or placebo (42 patients). Mifepristone was
given orally in a dose of 400 mg. Efficacy was assessed by change in t
he Bishop score within 48 hours after treatment; a score of 6 or great
er was considered a ''strict'' success. An ''extended'' success rate w
as defined, including all patients with scores of at least 6 or those
who delivered within 48 hours of treatment. Antenatal safety was asses
sed by fetal heart rate testing before and throughout labor. Neonatal
safety was assessed by Apgar score, arterial or venous pH of cord bloo
d, and blood glucose level during the first 48 hours. Analysis used St
udent t test for continuous variables, Kruskal-Wallis test for ordinal
data, and chi(2) for categoric variables. Results: Strict success was
achieved in 10 of 18 mifepristone patients (55%) evaluated for Bishop
score an day 2 versus 8 of 29 placebo patients (27.5%) (P = .004). Ex
tended success was achieved in 33 mifepristone patients (80.5%) and 21
placebo patients (50.0%) (P = .004). There were no statistical differ
ences with regard to number of cesareans or fetal and neonatal safety.
Conclusion: Mifepristone proved effective for cervical ripening and r
educed the time to delivery compared with placebo, but it did not impr
ove the rate of cesarean. Our study did not include enough pregnancies
to reach conclusions about fetal or neonatal safety. (Obstet Gynecol
1998; 92:487-92. (C) 1998 by The American College of Obstetricians and
Gynecologists.).