Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
For about 10% of pregnancies, it is necessary to induce delivery for medical reasons.
Prostaglandins alone can be used to perform cervical ripening in cases of immature cervix. In
France, dinoprostone is the own approved medication. It is in the form of gel or sustained
release device whose effectiveness and side effects are comparable. The vaginal misoprostol
has no marketing authorization in France, but is sometimes used. Some data in the scientific
literature have showed that its use with low-dose (25 mcg) vaginally did not lead to more
complications, was at least as effective and seems to be cost-effective compared with
dinoprostone. Misoprostol with this dose and route of administration is now recommended by
the American College of Obstetricians and Gynecologist (ACOG), Grade A (ACOG Practice
Bulletin August 2009). This is not the case in France (French HAS 2008 Guidelines on
induction of labor). According to HAS, the investigators still lack data on large samples to
confirm the benefits of misoprostol 25 mcg vaginally, in terms of efficiency, rate of
cesarean section, and lower cost compared to dinoprostone.
The primary objective is to demonstrate non-inferiority of vaginal misoprostol 25 mcg vs.
dinoprostone in terms of cesarian section occurence with a non-inferiority margin of +5%
difference.