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

NCT00501033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2008-05-08

No results posted yet for this study

Summary

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.

Conditions

  • Induction of Labor
  • Cesarean
  • Endometritis

Interventions

DEVICE

Mechanical induction of labor

DEVICE

Double Balloon

DEVICE

Foley Catheter

Sponsors & Collaborators

  • Western Galilee Hospital-Nahariya

    lead OTHER_GOV

Principal Investigators

  • Ido Solt, MD · Western Galilee Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-02-29
Completion
2008-05-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00501033 on ClinicalTrials.gov