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

Phase 4

Completed

• Conditions: Induction of Birth
• Interventions: Device: Foley Catheter; Device: Double Balloon Catheter

• Registration Number: NCT01091285
• Lead Sponsor: Haukeland University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-20
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-24
• Status Verified: 2010-04
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-08-16
• Last Update Posted: 2011-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• Singleton pregnancy above week 37
• Indication to induce birth
• Unripe cervix
• Term date set by US before week 21

Exclusion Criteria

• Ripe cervix
• Prematurity (<37w)
• IUFD
• Letal malformations
• Low lying placenta
• Multiple pregnancies
• Breakage of amniotic fluid
• The woman does not understand norwegian

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Balloon Catheter	Foley Catheter	Cervix Ripening is achieved by a single balloon catheter. Further induction by cytotec or/amniotomy and pitocin
Double balloon catheter	Double Balloon Catheter	Cervix Ripening is achieved by a double balloon catheter. Further induction by cytotec or/amniotomy and pitocin

Primary Outcome Measures

Name	Time	Method
Cervix dilatation >= 3cm	At cather removal	Cervix dilatation is assessed by vaginally examination at Catheter removal.

Trial Locations

Locations (1)

Womens Hospital, Haukeland University Hospital; 🇳🇴 Bergen, Norway