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Comparison of Pre-Induction Cervical Ripening

NCT01390233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2014-05-30

Study results available
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Summary

This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel.

The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed induction in the United States is rising. This has led to a renewed effort to examine the effectiveness of the varied methods of induction.

The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto Health Richland for a scheduled induction of labor will be offered enrollment in the trial. Patients who enroll in the study will be randomized into one of 3 study arms: urinary balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and prostaglandin gel. Randomization will be per sealed envelope from the locked nurse medication storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland. The investigator will be given the next sequentially numbered study randomization envelope by the patient's nurse. The randomization assignment will be unblinded to the patient and her physicians. If the patient is not in active labor 6 hours after initiation of the intervention, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.

Conditions

  • Failed Labour

Interventions

DRUG

Prepidil Gel

Pre-induction cervical ripening using dinoprostone gel in the vagina.

DEVICE

Urinary Balloon Catheter

Pre-induction cervical ripening using a urinary balloon catheter device.

OTHER

Combined Urinary Catheter & Prepidil Gel

Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment.

Sponsors & Collaborators

  • University of South Carolina

    lead OTHER

Principal Investigators

  • Paul C Browne, MD · University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-02-28
Completion
2013-05-31

Countries

  • United States

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 NCT01390233 on ClinicalTrials.gov