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

Condition(s) targeted: Prolonged Pregnancy; Nulliparity

Intervention: IMN (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
François Goffinet, MD, PhD, Study Director, Affiliation: Scientific Responsible

Overall contact:
Thomas Schmitz, MD, Phone: +33(0) 1 58 41 21 42, Email: thomas.schmitz@cch.aphp.fr

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Number of cesarean sections

Secondary outcome:

Number of labor inductions

Number of spontaneous labors

Cesarean for failed labor induction

Cesarean for FHR abnormalities

Cesarean for arrested labor

Bishop score at 41+2, 41+4, and labor induction

Isosorbide mononitrate adverse effects

Maternal satisfaction

Neonatal morbidity

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 prostaglandinE2 vaginal insert.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Thomas Schmitz, MD, Phone: +33(0) 1 58 41 21 42, Email: thomas.schmitz@cch.aphp.fr

Hopital Cochin, Paris 75014, France; Recruiting
Thomas Schmitz, MD, Principal Investigator

Starting date: June 2009
Ending date: September 2011
Last updated: June 29, 2009