Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Dinoprostone; Misoprostol

Criteria

Inclusion Criteria:

• singleton pregnancy

• Cephalic presentation

• Bishop ≤ 5

• ≤ 3 uterine contractions / 10 mn

• ≥ 36 weeks gestation

• Personally signed and dated informed consent document

Exclusion Criteria:

• History of cesarian-section

• uterine scar

• deceleration on Cardiotocogram (CTG)

• placenta praevia

• bleeding

• chorioamnionitis

• Fetal weight US ≥4500 g

• Contra-indication to vaginal delivery

• Hystory of myomectomy

• Herpes primoinfection or recurrence

• Allergy to prostaglandins