Status:
COMPLETED
Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Prolonged Pregnancy
Nulliparity
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 pos...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
1409 Patients enrolled
Trial Details
Trial ID
NCT00930618
Start Date
June 1 2009
End Date
April 1 2014
Last Update
December 1 2025
Active Locations (1)
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1
Robert Debré Hospital
Paris, France, 75019