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Overdue moms: new drug may cut C-Section risk

NCT ID NCT00930618

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a medicine called isosorbide mononitrate, given to help soften the cervix, could reduce the need for C-sections in first-time mothers whose pregnancies went past 41 weeks. Over 1,400 women took part. The goal was to see if this outpatient treatment could safely lower C-section rates and improve birth outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,409 people

The number who actually took part.

Start date

Jun 2009

Finished

Apr 2014

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Pregnancy, Prolonged

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nulliparity Prolonged pregnancy

Contacts and locations

Locations

  • Robert Debré Hospital

    Paris, 75019, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.