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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Prolonged Pregnancy; Nulliparity

Treatments: Drug: IMN; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00930618

P071212

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,409 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,409 participants in 2 patient groups, including a placebo group

IMN

Experimental group

Description:

Isosorbide mononitrate

Treatment:

Drug: IMN

Placebo

Placebo Comparator group

Description:

Administration of placebo of IMN

Treatment:

Drug: Placebo