Cervical ripening with mifepristone before labor induction: a randomized study.
OBJECTIVE
To determine the efficacy and safety of mifepristone for cervical ripening in post-term pregnancies.


METHODS
Women with post-term 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 the Bishop score within 48 hours after treatment; a score of 6 or greater was considered a "strict" success. An "extended" success rate was defined, including all patients with scores of at least 6 or those who delivered within 48 hours of treatment. Antenatal safety was assessed by fetal heart rate testing before and throughout labor. Neonatal safety was assessed by Apgar score, arterial or venous pH of cord blood, and blood glucose level during the first 48 hours. Analysis used Student t test for continuous variables, Kruskal-Wallis test for ordinal data, and chi2 for categoric variables.


RESULTS
Strict success was achieved in 10 of 18 mifepristone patients (55%) evaluated for Bishop score on day 2 versus 8 of 29 placebo patients (27.5%) (P=.004). Extended success was achieved in 33 mifepristone patients (80.5%) and 21 placebo patients (50.0%) (P=.004). There were no statistical differences with regard to number of cesareans or fetal and neonatal safety.


CONCLUSIONS
Mifepristone proved effective for cervical ripening and reduced the time to delivery compared with placebo, but it did not improve the rate of cesarean. Our study did not include enough pregnancies to reach conclusions about fetal or neonatal safety.
Department of Obstetrics and Gynecology, Hôpital Arnaud de Villeneuve, Montpellier, France.
P L
PL
Giacalone
V
V
Targosz
F
F
Laffargue
G
G
Boog
J M
JM
Faure
D000021:Abortifacient Agents, Steroidal / Q000097:blood / Q000627:therapeutic use*; D000328:Adult; D001034:Apgar Score; D020070:Cervical Ripening / Q000097:blood / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D007231:Infant, Newborn; D015735:Mifepristone / Q000097:blood / Q000627:therapeutic use*; D011247:Pregnancy
D000021:Abortifacient Agents, Steroidal; D015735:Mifepristone; D006854:Hydrocortisone