Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies
NOCETER
NOCETER, a Multicenter Double Blind Placebo-controlled Randomized Trial: Reduction of CEsareans in Post TERm Pregnancies: Impact of Outpatient Cervical Ripening With NO Donors
1 other identifier
interventional
1,409
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2009
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedDecember 1, 2025
November 1, 2025
4.5 years
June 29, 2009
November 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of cesarean sections
10 days
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (2)
IMN
EXPERIMENTALIsosorbide mononitrate
Placebo
PLACEBO COMPARATORAdministration of placebo of IMN
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert Debré Hospital
Paris, 75019, France
Related Publications (1)
Schmitz T, Fuchs F, Closset E, Rozenberg P, Winer N, Perrotin F, Verspyck E, Azria E, Carbonne B, Lepercq J, Maillard F, Goffinet F; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Outpatient cervical ripening by nitric oxide donors for prolonged pregnancy: a randomized controlled trial. Obstet Gynecol. 2014 Dec;124(6):1089-1097. doi: 10.1097/AOG.0000000000000544.
PMID: 25415159RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
François Goffinet, MD, PhD
Scientific Responsible
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2009
First Posted
June 30, 2009
Study Start
June 1, 2009
Primary Completion
December 1, 2013
Study Completion
April 1, 2014
Last Updated
December 1, 2025
Record last verified: 2025-11