Skip to main content
OpenTrials
Completed

NCT Number: NCT00501033

A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter

Hypothesis: The induction of labor in patients with unfavorable Bishop score is a challenging obstetrical process, and may be influenced or complicated by the cervical ripening method used. We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Induction of Labor Adnexal Diseases Cesarean Endometritis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Pelvic Inflammatory Disease Urogenital Diseases Uterine Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Western Galilee Hospital

Nahariya, 22100, Israel

About this study

We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis. The study will include 200 parturients, 100 primiparous and 100 multiparous women. We will randomize each group to induction with the foley catheter or the cervical ripening double balloon. We will compare the failure rates, cesarean section rate, infectious and other postpartum complications, especially endometritis.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Term pregnancy
  • Parturients candidates for mechanical induction of labor

Exclusion criteria

  • Suspected amnionitis
  • Vaginal discharge
  • Pre induction pyrexia
  • Immunocompromised parturients

Treatment and study plan

Mechanical induction of labor

Device

Double Balloon

Device

foley catheter

Device

Primary outcomes

  1. Success of labor induction

    Time frame: Postpartum period

Secondary outcomes

  1. Postpartum endometritis rate

    Time frame: The postpartum period

  2. Cesarean section rate

    Time frame: Delivery

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 13, 2007
Registry last updated
May 8, 2008

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.