NCT01091285

Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

A randomized controlled double blinded study to investigate whether a specially designed double balloon catheter is more efficient than a foley catheter for cervical ripening and induction of birth. 160 women with singleton term pregnancies with un ripe cervix and no contraindications for catheters will be included and randomized to either double og single balloon catheters for cervical ripening. Efficacy wil be assessed at removal of the catheter, measured by the amount of women where the cervix has become ripe enough for amniotomy. Our hypothesis is that double balloon catheters will give a greater amount of women where amniotomy upon catheter removal is possible. Secondary outcomes as time from induction till birth, vaginal deliveries and complications during or after birth for the mother or child will also become recorded.

Conditions

• Induction of Birth

Interventions

Type	Name	Description
DEVICE	Foley Catheter	Foley Catheter 16-19 H
DEVICE	Double Balloon Catheter	Double Balloon Catheter for 16-19H

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-03-24
• Last updated: 2011-08-17

Locations

1 site across 1 country: Norway