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NCT Number: NCT07492186

3-hour Versus 12-hour Double-balloon Catheter for Labor Induction

This study aims to demonstrate that a 3-hour ultra-short cervical ripening protocol using a double-balloon catheter significantly reduces the induction-to-birth interval by at least 6 hours compared to the standard 12-hour protocol. The study evaluates whether this reduction can be achieved without increasing cesarean section rates or maternal-fetal risks

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Scientific Justification: Labor induction affects 25% of pregnancies in France, with 70% requiring cervical ripening. While the 12-hour pose is standard, recent evidence suggests that shorter durations (6h) are effective but remain difficult to integrate into hospital workflows. Since the mechanical and physiological effects of the balloon are early phenomena, a 3-hour protocol could optimize bed management and patient comfort.

Strategy: Comparison between an experimental group (3-hour balloon pose followed by immediate active labor management regardless of Bishop score) and a control group (standard 12-hour balloon pose).

Follow-up: Participants are followed from the day of induction until hospital discharge (generally 2 to 10 days) to assess obstetric outcomes, neonatal safety, and maternal satisfaction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years,
  • singleton pregnancy
  • ≥ 34 weeks of gestation,
  • cephalic presentation,
  • Bishop score < 6,
  • healthy uterus,
  • standard indication for labor induction

Exclusion criteria

  • Minor patients,
  • ruptured membranes,
  • twin pregnancy,
  • fetal malpresentation,
  • placenta previa,
  • previous uterine scar,
  • known fetal malformation

Treatment and study plan

Cook® double-balloon catheter

Device

For both arms, the same double-balloon device is used. After the allocated time (3h or 12h) or spontaneous expulsion, active labor management is initiated, including early amniotomy and/or oxytocin administration

Primary outcomes

  1. induction-to-birth interval reduction

    Time frame: balloon insertion and birth of the child

    Time (in hours) between the effective initiation of labor induction (balloon insertion) and the birth of the child

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de PAU

Other

Registry information

Official study title

Labor Induction With Double-balloon Catheter Placed for 3 Hours Versus 12 Hours in Patients With an Indication for Induction: a Randomized Controlled Trial

Acronym: BAL3H

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.