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

HaEmek Medical Center, Israel293 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

293

Conditions

Induction of Labor

Interventions

Foley catheterDEVICE

Single balloon catheter

Atad catheterDEVICE

Double balloon catheter

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 48 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Ob/Gyn, Ha'Emek Medical Center

Afula, Israel

Outcomes

Primary Outcomes

Average Time in Hours From Insertion of the Catheter Until Delivery

Time frame: At the end of the study

Secondary Outcomes

To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups

Time frame: At the end of the study

Data from ClinicalTrials.gov

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