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

November 24, 2025 updated by: Assistance Publique - Hôpitaux de Paris

NOCETER, a Multicenter Double Blind Placebo-controlled Randomized Trial: Reduction of CEsareans in Post TERm Pregnancies: Impact of Outpatient Cervical Ripening With NO Donors

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1409

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Robert Debré Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of cesarean sections
Time Frame: 10 days
10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of labor inductions
Time Frame: 10 days
10 days
Number of spontaneous labors
Time Frame: 10 days
10 days
Cesarean for failed labor induction
Time Frame: 10 days
10 days
Cesarean for FHR abnormalities
Time Frame: 10 days
10 days
Cesarean for arrested labor
Time Frame: 10 days
10 days
Mean time between randomisation and spontaneous labor
Time Frame: 10 days
10 days
Isosorbide mononitrate adverse effects
Time Frame: 10 days
10 days
Maternal satisfaction
Time Frame: 10 days
10 days
Neonatal morbidity
Time Frame: 10 days
10 days
Mean time between randomisation and delivery
Time Frame: 10 days
10 days
Mean duration of labor
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Study Director: François Goffinet, MD, PhD, Scientific Responsible

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (Estimated)

June 30, 2009

Study Record Updates

Last Update Posted (Estimated)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P071212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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