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Ripening Interventions: Prostaglandins vs EASI Catheter

NCT00383942 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-03-13

Study results available
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Summary

The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion of patients delivered by cesarean section for fetal intolerance of labor versus vaginal delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI catheter are less likely to undergo cesarean section for fetal intolerance of labor when compared to women who receive misoprostol.

Conditions

  • Cesarean Section

Interventions

DRUG

Misoprostol

Misoprostol,25 micrograms every 4 hours.

DEVICE

Catheter

A catheter with extra amniotic saline infusion (EASI) is placed in the uterus and applies pressure to the cervix to cause it to ripen

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Principal Investigators

  • Scott Graziano, MD · Loyola University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-06-18
Completion
2008-06-18
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT00383942 on ClinicalTrials.gov