Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

Phase 3

Withdrawn

• Conditions: Premature Birth; Placenta Previa
• Interventions: Procedure: Placement of a Cervical Cerclage; Procedure: Standard Expectant Management

• Registration Number: NCT01442207
• Lead Sponsor: Obstetrix Medical Group

Brief 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.

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 Timeline

• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-09-26
• Study First Posted: 2011-09-28
• Study Start: 2012-03
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placement of Cervical Cerclage	Placement of a 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
Expectant Management	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, Premature rupture of the membranes (PROM) \> 34 wks, worsening maternal or fetal condition ) * Fetal Fibronectin (fFN) test collected at the time of transvaginal Ultrasound.

Primary Outcome Measures

Name	Time	Method
Gestational age (GA) at birth	measure taken in the first 23 hours after birth.	The gestational age (GA) of the baby noted at birth

Secondary Outcome Measures

Name	Time	Method
Newborn Birth weight	measured within 1-2 days after birth	Newborn Birth weight measure within 1-2 days after birth.
Need for Maternal Blood Product replacement	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.
Number of participants delivering prematurely following hemorrhage who have a positive fFN test.	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.