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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prolonged Pregnancy, Nulliparity

Intervention / Treatment
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* Drug: IMN
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMN<br>Isosorbide mononitrate | Drug: IMN<br>* Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations<br>|
| Placebo Comparator: Placebo<br>Administration of placebo of IMN | Drug: Placebo<br>* Administration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cesarean sections |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prolonged pregnancy, Nulliparity, Cervical ripening, Induced labor, Cesarean section