Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix

Not Applicable

Completed

• Conditions: Induction of Labor
• Interventions: Device: Atad catheter; Device: Foley catheter

• Registration Number: NCT00690040
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-31
• Study Start: 2008-06
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-04
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2013-03-19
• Status Verified: 2013-05
• Results First Submitted QC: 2016-09-01
• Last Update Submitted: 2016-09-01
• Results First Posted: 2016-10-24
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 293

Inclusion Criteria

• Induction of labor is indicated
• Gestational age between 24 - 42 weeks
• Singleton pregnancy
• Bishop score less than 7

Exclusion Criteria

• Any contraindication for vaginal delivery

• Previous cesarean delivery

• Low lying placenta

• Rupture of membranes

• Fetal malformations incompatible with life

• intrauterine fetal death

• Amnionitis

• Genital viral infection (HIV, hepatitis C virus

  , hepatitis B virus)

• Allergy to latex

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Atad catheter	Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
1	Foley catheter	Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)

Primary Outcome Measures

Name	Time	Method
Average Time in Hours From Insertion of the Catheter Until Delivery	At the end of the study

Secondary Outcome Measures

Name	Time	Method
To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups	At the end of the study

Trial Locations

Locations (1)

Department of Ob/Gyn, Ha'Emek Medical Center; 🇮🇱 Afula, Israel