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

NCT ID NCT02907060

Disease control Sponsor: University Hospital, Tours 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two ways to soften the cervix (cervical ripening) in women with prolonged pregnancies (41+ weeks). One method uses a drug called Propess (dinoprostone), 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. The results could help doctors choose the safest approach for overdue babies.

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, gentler way to start labor in overdue pregnancies, reducing emergency C-sections.
What could go wrong
This trial is already completed, so results are known. The balloon may not reduce C-sections as hoped, and both methods have risks like infection or uterine hyperstimulation.

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

1,224 people

The number who actually took part.

Started

Jan 2017

Finished

Dec 2018

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: * Pregnant women * ≥ 18 years old * With a singleton cephalic pregnancy between ≥41+0 weeks and ≤ 42+0 weeks of gestation * Gestational age estimated from the first trimester ultrasound (realized between 11 and 13+6 weeks of gestation) * With a decision of induction of labour * Written informed consent obtained from subject * Subject covered by or having the rights to the French Social Security system Exclusion Criteria: * Bishop score ≥ 6 (favourable cervix) * Non cephalic presentation (breech, transverse) * Severe preeclampsia defined as the presence of preeclampsia with at least one of the following items : * Severe maternal hypertension (systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg) * Renal failure with oliguria (\< 500 ml/24h) or creatinine \> 135μmol/L, or proteinuria \> 5 g/day * Pulmonary oedema, epigastric pain or HELLP syndrom (hemolysis, elevated liver enzyme, low platelets) * Eclampsia or neurologic persisting symptoms (visual disturbances, headache, increased reflexes) * Thrombopenia \< 100 G/L * Prior caesarean section or uterine scar * Placenta praevia * Suspected genital herpes infection * Known VIH seropositivity (confirmed by blood serology) * Premature rupture of membranes (PROM - continual leaking of amniotic fluid or positive test in favour of PROM) * Foetus with suspected severe congenital abnormalities * Pathological fetal heart rate * Contra-indications to Propess® * Contra-indications for using Cook® Cervical Ripening Balloon * Women under guardianship or trusteeship

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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.

Prolonged pregnancy

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

More trials for these conditions

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