MedDataX Logo

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

NCT ID: NCT00930618

Last Updated: 2016-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1409 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prolonged Pregnancy Nulliparity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Prolonged pregnancy Nulliparity Cervical ripening Induced labor Cesarean section

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IMN

Isosorbide mononitrate

Group Type EXPERIMENTAL

IMN

Intervention Type DRUG

Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations

Placebo

Administration of placebo of IMN

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IMN

Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations

Intervention Type DRUG

Placebo

Administration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

François Goffinet, MD, PhD

Role: STUDY_DIRECTOR

Scientific Responsible

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Robert Debré Hospital

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25415159 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P071212

Identifier Type: -

Identifier Source: org_study_id