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OpenTrials
Completed

NCT Number: NCT00690040

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

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.

Completed

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Key information

Conditions

Induction of Labor

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ob/Gyn, Ha'Emek Medical Center

Afula, Israel

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

foley catheter

Device

Single balloon catheter

Atad catheter

Device

Double balloon catheter

Primary outcomes

  1. Average Time in Hours From Insertion of the Catheter Until Delivery

    Time frame: At the end of the study

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 4, 2008
Registry last updated
Oct 24, 2016

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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