Cervical ripening balloon left in place for 3 hours vs 12 hours during labor induction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares two durations of Cook Cervical Ripening Balloon placement during induction of labor. Participants are randomized to have the balloon removed after about 3 hours or after 12 hours, aiming to see if shorter placement can shorten time to delivery and improve outcomes. The study uses standard insertion procedures and follows safety criteria to monitor for complications and maternal comfort. Eligible participants are adults 18–45 years with singleton pregnancies between 37 and 41 weeks, with no contraindications to vaginal delivery. Results will inform whether shorter balloon duration can maintain efficacy while potentially reducing labor time and discomfort.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Nulliparous or multiparous pregnant women.
* Gestational age between 37 0/7 and 41 6/7 weeks of gestation.
* Maternal age between 18 and 45 years.
* Participant has provided signed informed consent.

Exclusion Criteria:

* Presence of any contraindications for vaginal delivery.
* Multifetal gestation.
* Rupture of membranes prior to balloon insertion.
* Favorable cervix, defined as a Bishop score greater than 6.
* Cervical dilation greater than 2 cm.
* Previous cesarean delivery or any other prior major uterine surgery.

Where it's running

• Rambam Health Care Campus
  Haifa, Israel Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pain relief for cervical ripening balloon during labor induction

  This study tests whether applying lidocaine gel inside the vagina can reduce pain from placing a cervical ripening balloon for women undergoing labor induction.

  Recruiting Phase 2 Beth Israel Deaconess Medical Center · Boston, Massachusetts · NCT07268118

• Dexamethasone with or without misoprostol to help start labor at term

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• Using Calcium Carbonate to Improve Labor Contractions

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  Recruiting Phase 4 Weill Medical College of Cornell University · New York, New York · NCT06580782

• Using virtual reality hypnosis for pain management during labor

  This study tests if using virtual reality hypnosis can help women manage pain during the early stages of labor without medication.

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens · NCT06502457

• Ophthalmic Artery Doppler to predict labor problems before induction

  This study tests whether measuring the ophthalmic artery Doppler in pregnant people at term who are being induced can help predict intrapartum fetal distress.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome, rm · NCT07846137

• Natural cervical ripening to delay pharmacological induction of labor

  This pilot study tests whether nipple stimulation and membrane sweeping can help some pregnant people go into labor on their own without needing drugs.

  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07587632

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.