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Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

NCT01442207 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-12-19

No results posted yet for this study

Summary

The purpose of the study is to compare the role of cervical cerclage versus expectant management in women with complete placenta previa (≥ 10mm over internal os) presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of pregnancy.

Conditions

  • Premature Birth
  • Placenta Previa

Interventions

PROCEDURE

Placement of a Cervical Cerclage

Surgical placement of a cervical cerclage

PROCEDURE

Standard Expectant Management

Participants assigned to the expectant management group will be followed by their doctor and managed per standard management which includes: * Standard management for placenta previa. * Hospital admission for vaginal bleeding/hemorrhage * Antenatal corticosteroids \> 24w0d of gestation * Tocolytic therapy per physician's discretion * Magnesium sulfate for neuroprotection * Fetal Heart Rate Monitoring * Avoidance of digital examinations of the cervix * Elective delivery no earlier than 36w0d gestation unless indicated (uncontrolled hemorrhage, imminent delivery, PROM \> 34 wks, worsening maternal or fetal condition ) * Fetal Fibronectin (fFN) test collected at the time of transvaginal Ultrasound.

Sponsors & Collaborators

  • Obstetrix Medical Group

    lead INDUSTRY

Principal Investigators

  • Irene Stafford, MD · Obstetrix Medical Group of Tucson.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-05-31
Completion
2013-05-31

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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 NCT01442207 on ClinicalTrials.gov