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OpenTrials
Completed

NCT Number: NCT01091285

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

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.

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Key information

Conditions

Induction of Birth

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Womens Hospital, Haukeland University Hospital

Bergen, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

foley catheter

Device

Foley Catheter 16-19 H

Double balloon catheter

Device

Double Balloon Catheter for 16-19H

Other names: Cervical Ripening Balloon, Cook Medical

Primary outcomes

  1. Cervix dilatation >= 3cm

    Time frame: At cather removal

    Cervix dilatation is assessed by vaginally examination at Catheter removal.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 24, 2010
Registry last updated
Aug 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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