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

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ClinicalTrials.gov Identifier: NCT01091285
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : August 17, 2011
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Induction of Birth Device: Foley Catheter Device: Double Balloon Catheter Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study
Study Start Date : March 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Active Comparator: Single Balloon Catheter
Cervix Ripening is achieved by a single balloon catheter. Further induction by cytotec or/amniotomy and pitocin
Device: Foley Catheter
Foley Catheter 16-19 H

Active Comparator: Double balloon catheter
Cervix Ripening is achieved by a double balloon catheter. Further induction by cytotec or/amniotomy and pitocin
Device: Double Balloon Catheter
Double Balloon Catheter for 16-19H
Other Name: Cervical Ripening Balloon, Cook Medical




Primary Outcome Measures :
  1. Cervix dilatation >= 3cm [ Time Frame: At cather removal ]
    Cervix dilatation is assessed by vaginally examination at Catheter removal.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091285


Locations
Norway
Womens Hospital, Haukeland University Hospital
Bergen, Norway
Sponsors and Collaborators
Haukeland University Hospital

Responsible Party: Birte Haugland, Dr, Womens hospital, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01091285     History of Changes
Other Study ID Numbers: 1728a (REK)
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: August 17, 2011
Last Verified: April 2010