NCT00930618

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,409 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Prolonged Pregnancy
• Nulliparity

Interventions

Type	Name	Description
DRUG	IMN	Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations
DRUG	Placebo	Administration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-12-01
• Completion: 2014-04-01
• First posted: 2009-06-30
• Last updated: 2025-12-01

Locations

1 site across 1 country: France