Balloon vs drug: which is safer for inducing labor in overdue pregnancies?

NCT ID NCT02907060

First seen Jan 10, 2026 · Last updated Jun 22, 2026 · Updated 27 times

Summary

This study tested two ways to prepare the cervix for labor in women who are 41 to 42 weeks pregnant. One method uses a drug called Propess (dinoprostone), and the other uses a soft balloon device placed in the cervix. The goal was to see which method leads to fewer C-sections due to signs of fetal distress. Over 1,200 women took part in this completed Phase 3 trial.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • CHU CAEN

    Caen, 14033, France

  • Ch Chartres

    Chartres, France

  • Ch Departemental Vendee

    La Roche-sur-Yon, 85925, France

  • Ch Pontoise

    Cergy-Pontoise, 95303, France

  • Chi Poissy

    Poissy, France

  • Chru Tours

    Tours, 37044, France

  • Chu Brest

    Brest, France

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63001, France

  • Chu Nantes

    Nantes, 44093, France

  • Chu Reims

    Reims, 51092, France

  • Chu Rennes

    Rennes, France

  • Chu Saint Etienne

    Saint-Priest-en-Jarez, 42270, France

  • Chu Toulouse

    Toulouse, France

  • Hopital Saint Joseph

    Marseille, 13008, France

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

dinoprostone (Propess) and a double transcervical balloon (Cook Cervical Ripening Balloon)

What this could lead to

If the balloon works better, it could offer a safer way to start labor in overdue pregnancies, reducing emergency C-sections for fetal distress.

What could go wrong

This is a completed Phase 3 trial, but results may not apply to all hospitals or pregnancies. The balloon might not lower C-section rates as hoped.

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.