Reduction of Cesareans by Nitric Oxide (NO) Donors in Pos... | NCT00930618

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

NCT00930618

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Dec 1, 2025Actual

Enrollment

1,409Actual

Phase

Phase 3

Conditions

Prolonged Pregnancy
Nulliparity

Interventions

IMN
Placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2013Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jun 29, 2009

First Submission Date that Met QC Criteria

Jun 29, 2009

First Posted Date

Jun 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2025

Last Update Posted Date

Dec 1, 2025Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,409Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IMN	Experimental	Isosorbide mononitrate	Drug: IMN
Placebo	Placebo Comparator	Administration of placebo of IMN	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMN	Drug	Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations	IMN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of cesarean sections		10 days

Secondary Outcomes

Measure	Description	Time Frame
Number of labor inductions		10 days
Number of spontaneous labors		10 days
Cesarean for failed labor induction

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François Goffinet, MD, PhD	Scientific Responsible	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Robert Debré Hospital		Paris		75019	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25415159	Result	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.

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases