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NCT Number: NCT07689357

Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement

The goal of this clinical trial is to learn if a shorter duration of cervical ripening balloon (CRB) placement can reduce the time to delivery in pregnant women undergoing induction of labor.

The main questions it aims to answer are:

Does placing the cervical ripening balloon for 3 hours or less result in a shorter interval from insertion to delivery compared to the standard 12-hour placement?

Does a shorter 3-hour balloon placement lead to better pregnancy outcomes, fewer complications, and lower maternal discomfort?

Researchers will compare a group of participants who have the balloon removed after 3 hours to a control group who have the balloon removed after 12 hours to see if the shorter duration decreases the overall time to delivery.

Participants will:

Sign an informed consent and be randomized into one of the two groups (3 hours vs. 12 hours).

Undergo the standard procedure of a double-lumen Cook cervical ripening balloon insertion.

Have the balloon removed after approximately 3 hours or 12 hours depending on their assigned group.

Proceed with amniotomy or Pitocin use at the discretion of the labor and delivery physician.

Complete a Birth Satisfaction Scale questionnaire and have their maternal and neonatal health outcomes tracked from the hospital's database.

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Key information

Conditions

Labor Induction Cervical Ripening and Induction of Labor

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Cook Cervical Ripening Balloon 3 hours

Device

Use of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 3 hours.

Cook Cervical Ripening Balloon 12 hours

Device

Use of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 12 hours.

Primary outcomes

  1. Insertion-to-Delivery Time Interval

    Time frame: From the time of balloon insertion up to delivery (approximately 48 hours).

    The time interval (in hours) from the successful insertion of the cervical ripening balloon to the time of fetal delivery (whether vaginal or cesarean section).

Secondary outcomes

  1. Mode of Delivery

    Time frame: At the time of delivery.

    The rates of successful vaginal deliveries, instrumental deliveries (vacuum), and cesarean deliveries between the two groups.

  2. Time to Active Phase and Second Stage of Labor

    Time frame: From balloon insertion up to delivery, assessed up to 48 hours after balloon insertion.

    The duration (in hours) from balloon insertion to the onset of the active phase of labor, and the duration of the second stage of labor.

  3. Maternal Complications

    Time frame: From balloon insertion up to 48 hours postpartum.

    Composite rate of maternal complications including chorioamnionitis, postpartum hemorrhage (PPH, defined as estimated blood loss greater than 1000 mL), need for blood transfusion, maternal fever during or after delivery, and obstetric anal sphincter injuries (OASIS).

  4. Adverse Neonatal Outcomes

    Time frame: From birth up to newborn discharge or 7 days of life.

    Composite rate of neonatal outcomes including birthweight, Apgar scores at 1 and 5 minutes (range 0-10; higher scores indicate better neonatal condition), neonatal umbilical cord pH, rates of respiratory complications, admission to the Neonatal Intensive Care Unit (NICU), and suspected or confirmed neonatal sepsis.

  5. Duration of Hospitalization

    Time frame: From admission for induction up to hospital discharge (approximately 3-5 days).

    The total length of maternal hospital stay (in days) from the day of admission for labor induction to the day of postpartum discharge.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Comparison of Labor Induction With Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement: a Randomized Controlled Trail

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 8, 2026
Registry last updated
Jul 8, 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.

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