Overview

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

Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this trial is to determine whether cervical ripening with isosorbide mononitrate reduce caesarean section in women with post term pregnancies.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
Isosorbide-5-mononitrate
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