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

Phase 3

Completed

• Conditions: Nulliparity; Prolonged Pregnancy
• Interventions: Drug: IMN; Drug: Placebo

• Registration Number: NCT00930618
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Primary Completion: 2013-12
• Study Completion: 2014-04
• Status Verified: 2014-06
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1409

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMN	IMN	Isosorbide mononitrate
Placebo	Placebo	Administration of placebo of IMN

Primary Outcome Measures

Name	Time	Method
Number of cesarean sections	10 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Robert Debré Hospital; 🇫🇷 Paris, France