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

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ClinicalTrials.gov Identifier: NCT00690040
Recruitment Status : Completed
First Posted : June 4, 2008
Results First Posted : October 24, 2016
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
Raed Salim, 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.

Condition or disease Intervention/treatment Phase
Induction of Labor Device: Foley catheter Device: Atad catheter Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 293 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
Study Start Date : June 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Active Comparator: 1
Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
Device: Foley catheter
Single balloon catheter

Active Comparator: 2
Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
Device: Atad catheter
Double balloon catheter




Primary Outcome Measures :
  1. Average Time in Hours From Insertion of the Catheter Until Delivery [ Time Frame: At the end of the study ]

Secondary Outcome Measures :
  1. To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups [ Time Frame: At the end of the study ]


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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00690040


Locations
Israel
Department of Ob/Gyn, Ha`Emek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Raed Salim, MD Department of Ob/Gyn, Ha`Emek Medical Center, Afula, and Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Raed Salim, MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00690040     History of Changes
Other Study ID Numbers: 0007-08-EMC
First Posted: June 4, 2008    Key Record Dates
Results First Posted: October 24, 2016
Last Update Posted: October 24, 2016
Last Verified: May 2013

Keywords provided by Raed Salim, HaEmek Medical Center, Israel:
Induction of labor
Ripening
Single balloon catheter
Double balloon catheter