Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies

NOCETER, a Multicenter Double Blind Placebo-controlled Randomized Trial: Reduction of CEsareans in Post TERm Pregnancies: Impact of Outpatient Cervical Ripening With NO Donors

The purpose of this trial is to determine whether cervical ripening with isosorbide mononitrate reduce caesarean section in women with post term pregnancies.

The purpose of this trial is to determine whether cervical ripening with 40 mg of isosorbide mononitrate given intravaginally at 41+0, 41+2 and 41+4 weeks reduce cesarean section in nullipara with post term pregnancies. Treatments will be administered by midwifes in the maternity wards, women will be allowed to go back home in case of Bishop score<6. Otherwise labor will be induced with oxytocin. If undelivered at 41+5, women with Bishop score<6 will be induced with prostaglandins according to local protocols.

Inclusion criteria :

• Age > or = 18 years old
• TAS > or = 95 mmHg
• Singleton
• Nulliparity
• Term > or = 41 weeks + 0 day
• Bishop score < or = 5
• Vertex presentation
• Intact membranes
• No contra-indications of the study treatment
• No maternal or fetal diseases which could indicate immediate labor induction
• Written informed consent

Exclusion criteria :

• Multiple pregnancy
• Multiparity
• Term < 41 weeks
• Bishop score > 5
• Breech presentation
• Rupture of the membranes
• Previous cesarean
• Indication to immediate labor induction
• Contraindications to isosorbide mononitrate
• No co-administration of antihypertensive drugs
• No social security