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

Haukeland University Hospital

Status and phase: Completed; Phase 4

Conditions: Induction of Birth

Treatments: Device: Foley Catheter; Device: Double Balloon Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01091285

1728a (REK)

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Single Balloon Catheter

Active Comparator group

Description:

Cervix Ripening is achieved by a single balloon catheter. Further induction by cytotec or/amniotomy and pitocin

Treatment:

Device: Foley Catheter

Double balloon catheter

Active Comparator group

Description:

Cervix Ripening is achieved by a double balloon catheter. Further induction by cytotec or/amniotomy and pitocin

Treatment:

Device: Double Balloon Catheter