Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 20, 2010
CompletedFirst Posted
Study publicly available on registry
March 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedAugust 17, 2011
April 1, 2010
10 months
March 20, 2010
August 16, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Cervix dilatation >= 3cm
Cervix dilatation is assessed by vaginally examination at Catheter removal.
At cather removal
Study Arms (2)
Single Balloon Catheter
ACTIVE COMPARATORCervix Ripening is achieved by a single balloon catheter. Further induction by cytotec or/amniotomy and pitocin
Double balloon catheter
ACTIVE COMPARATORCervix Ripening is achieved by a double balloon catheter. Further induction by cytotec or/amniotomy and pitocin
Interventions
Double Balloon Catheter for 16-19H
Eligibility Criteria
You may qualify if:
- Singleton pregnancy above week 37
- Indication to induce birth
- Unripe cervix
- Term date set by US before week 21
You may not qualify if:
- Ripe cervix
- Prematurity (\<37w)
- IUFD
- Letal malformations
- Low lying placenta
- Multiple pregnancies
- Breakage of amniotic fluid
- The woman does not understand norwegian
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Womens Hospital, Haukeland University Hospital
Bergen, Norway
Related Publications (1)
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PMID: 36996264DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 20, 2010
First Posted
March 24, 2010
Study Start
March 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
August 17, 2011
Record last verified: 2010-04