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Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)

NCT00201656 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2014-12-19

No results posted yet for this study

Summary

The purpose of this study is to determine whether retention of cervical cerclage after PPROM improves latency (without a significant increase in chorioamnionitis) and lessens neonatal morbidity.

Conditions

  • Fetal Membranes, Premature Rupture

Interventions

PROCEDURE

Retention of Cerclage

Retain Cerclage until clinical removal is indicated by protocol

PROCEDURE

Removal of Cerclage

Immediate removal of Cerclage following randomization

PROCEDURE

Removal vs. Retention of Cervical Cerclage

Immediate removal of cerclage following randomization vs. retention of cerclage until labor, chorioamnionitis, or fetal distress

Sponsors & Collaborators

  • Obstetrix Medical Group

    lead INDUSTRY

Principal Investigators

  • Kimberly Maurel, RN, MSN, CNS · Obstetrix Medical Group, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2013-11-30
Completion
2014-04-30

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 NCT00201656 on ClinicalTrials.gov