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NCT01091285 Clinical Trial

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

Induction of Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01091285
Other study ID # 1728a (REK)
Secondary ID
Status Completed
Phase Phase 4
First received March 20, 2010
Last updated August 16, 2011
Start date March 2010
Est. completion date January 2011

Study information
Verified date April 2010
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Foley Catheter
Foley Catheter 16-19 H
• Double Balloon Catheter
Double Balloon Catheter for 16-19H

Locations
Country Name City State
Norway Womens Hospital, Haukeland University Hospital Bergen

Sponsors (1)
Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cervix dilatation >= 3cm Cervix dilatation is assessed by vaginally examination at Catheter removal. At cather removal No