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

Phase 3 Completed 1409 enrolled Assistance Publique - Hôpitaux de Paris URC-CIC Paris Descartes Necker Cochin · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2009-06
Primary completion: 2013-12
Completion: 2014-04

Outcome

Missed primary endpoint

paper Outpatient cervical ripening with vaginal isosorbide mononitrate for prolonged pregnancy in nulliparous women does not reduce cesarean delivery rate. PMID 25415159 ↗

Publications

Results Schmitz T, Fuchs F, Closset E, Rozenberg P, Winer N, Perrotin F, Verspyck E, Azria E, Carbonne B, Lepercq J, Maillard F, Goffinet F; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Outpatient cervical ripening by nitric oxide donors for prolonged pregnancy: a randomized controlled trial. Obstet Gynecol. 2014 Dec;124(6):1089-1097. doi: 10.1097/AOG.0000000000000544.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isosorbide Mononitrate	Other / unclassified	40 mg	Other

Indications

No indication recorded.