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

NCT00930618 — Phase 3, Completed, 1409 participants, Assistance Publique - Hôpitaux de Paris

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

Registry	NCT00930618, acronym NOCETER
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	1409 (Actual)
Sponsor	Assistance Publique - Hôpitaux de Paris (Other); collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions	Prolonged Pregnancy, Nulliparity
Interventions	IMN, Placebo (Drug)
Dates	start 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 in France

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
IMN	Experimental	Drug: IMN	Isosorbide mononitrate
Placebo	Placebo comparator	Drug: Placebo	Administration of placebo of IMN

IMN (Drug): Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations
Placebo (Drug): Administration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration

+Outcome measures

Primary outcomes

Number of cesarean sections [10 days]

Secondary outcomes

Number of labor inductions [10 days]
Number of spontaneous labors [10 days]
Cesarean for failed labor induction [10 days]
Cesarean for FHR abnormalities [10 days]
Cesarean for arrested labor [10 days]
Mean time between randomisation and spontaneous labor [10 days]
Isosorbide mononitrate adverse effects [10 days]
Maternal satisfaction [10 days]
Neonatal morbidity [10 days]
Mean time between randomisation and delivery [10 days]
Mean duration of labor [10 days]

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Robert Debré Hospital	Paris	France

+Publications

Results publication: 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. PMID 25415159

+Investigators

François Goffinet, MD, PhD, Study director, Scientific Responsible

My Notes

Public

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