Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

December 17, 2014 updated by: Obstetrix Medical Group

Cerclage Placement for the Prevention of Preterm Birth in Women With Placenta Previa - A Multicenter Randomized Controlled Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to perform a large multi-center randomized trial comparing the role of cervical cerclage versus expectant management in women with placenta previa presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of gestation. In addition, the role of fetal fibronectin (fFN) for the prediction of preterm birth and hemorrhage will be elucidated. The hypothesis is that placement of a cervical cerclage between 18w0d to 26w0d in patients with a short cervix and complete placenta previa will decrease preterm birth as compared to expectantly managing these patients.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton pregnancy, ≥ 18yrs old
  • GA 18w0d to 26w0d inclusive @ time of enrollment
  • Documentation of complete placenta previa (≥ 10mm over internal os)
  • Agrees to participate in trial and signs/date an informed consent form.

Exclusion Criteria:

  • Contraindication to expectant management (i.e. active labor, Non-reassuring fetal heart rate (NRFHR), Intrauterine fetal demise (IUFD), uncontrolled hemorrhage)
  • Fetal condition likely to cause serious neonatal morbidity independent of GA (e.g. hydrops, fetal viral infections, fetal malformations likely to need surgery like hydrocephalus, neural tube defects, cardiac defects, abdominal wall defects)
  • Known uterine anomaly at time of enrollment
  • History of two or more prior cesarean deliveries
  • Suspected placenta accrete, increta or percreta on US at enrollment
  • Cervical cerclage present at time of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Placement of Cervical Cerclage
Cervical Cerclage is to be placed in an inpatient hospital setting within 24 to 72 hours of being assigned to this treatment group
Procedure: Placement of a Cervical Cerclage
Surgical placement of a cervical cerclage
Other Names:
  • cerclage
Placebo Comparator: 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, Premature rupture of the membranes (PROM) > 34 wks, worsening maternal or fetal condition )
  • Fetal Fibronectin (fFN) test collected at the time of transvaginal Ultrasound.
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.
Other Names:
  • Expectant Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational age (GA) at birth
Time Frame: measure taken in the first 23 hours after birth.
The gestational age (GA) of the baby noted at birth
measure taken in the first 23 hours after birth.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Newborn Birth weight
Time Frame: measured within 1-2 days after birth
Newborn Birth weight measure within 1-2 days after birth.
measured within 1-2 days after birth
Need for Maternal Blood Product replacement
Time Frame: measured from the time participant is enrolled in the study until 30 days after delivery.(approximately 40 weeks)
Maternal need for blood product replacement such as Fresh Frozen Plasma.
measured from the time participant is enrolled in the study until 30 days after delivery.(approximately 40 weeks)
Number of participants delivering prematurely following hemorrhage who have a positive fFN test.
Time Frame: measured at delivery
Measure the total number of patients (participants) who delivered prematurely as a result of hemorrhage who also had a positive fFN test.
measured at delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Obstetrix Medical Group

Investigators

  • Principal Investigator: Irene Stafford, MD, Obstetrix Medical Group of Tucson.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 15, 2011

First Submitted That Met QC Criteria

September 26, 2011

First Posted (Estimate)

September 28, 2011

Study Record Updates

Last Update Posted (Estimate)

December 19, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBX 0018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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