Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening

University of Washington

Status: Completed

Conditions: Pre-induction Cervical Ripening

Treatments: Device: mechanical pre-induction cervical ripening

Study type: Interventional

Funder types: Other

Identifiers

NCT02344459

36685-D

Details and patient eligibility

About

The purpose of this study is to perform a randomized controlled trial to compare the efficacy of 80mL double balloon catheter versus a 30mL single catheter balloon for pre-induction cervical ripening by evaluating the change in Bishop score.

Enrollment: 105 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Bishop score of 5 or less
• Singleton
• Cephalic presentation
• Fewer than 4 contractions in 10 minutes
• Reactive fetal monitoring

Exclusion criteria

• Non-vertex presentation
• Placenta previa
• Vasa previa
• Unexplained vaginal bleeding
• Active herpes simplex virus infection
• Non-English speaking
• Previous attempt at an induction of labor in the current pregnancy
• Prolapsed umbilical cord
• More than one prior cesarean delivery or history of classical cesarean delivery
• Patients receiving or planning to undergo exogenous prostaglandin administration as the primary induction agent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

80mL double balloon catheter (Cook catheter®)

Experimental group

Treatment:

Device: mechanical pre-induction cervical ripening

30mL single Foley balloon catheter

Active Comparator group

Treatment:

Device: mechanical pre-induction cervical ripening