Clinical trial NCT00930618: Reduction of Cesareans by Nitric Oxide (NO) Donors in 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prolonged Pregnancy
Nulliparity
Keywords: Prolonged pregnancy
Nulliparity
Cervical ripening
Induced labor
Cesarean section
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-06-30
Enrollment: 1409
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Number of cesarean sections
timeFrame: 10 days
Secondary outcomes:
measure: Number of labor inductions
timeFrame: 10 days
measure: Number of spontaneous labors
timeFrame: 10 days
measure: Cesarean for failed labor induction
timeFrame: 10 days
measure: Cesarean for FHR abnormalities
timeFrame: 10 days
measure: Cesarean for arrested labor
timeFrame: 10 days
measure: Mean time between randomisation and spontaneous labor
timeFrame: 10 days
measure: Isosorbide mononitrate adverse effects
timeFrame: 10 days
measure: Maternal satisfaction
timeFrame: 10 days
measure: Neonatal morbidity
timeFrame: 10 days
measure: Mean time between randomisation and delivery
timeFrame: 10 days
measure: Mean duration of labor
timeFrame: 10 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debré Hospital
Study officials:
affiliation: Scientific Responsible
name: François Goffinet, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.