Status:
WITHDRAWN
Cerclage for Prevention on Preterm Birth in Women With Placenta Previa
Lead Sponsor:
Obstetrix Medical Group
Conditions:
Premature Birth
Placenta Previa
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 len...
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 shortene...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01442207
Start Date
March 1 2012
End Date
May 1 2013
Last Update
December 19 2014
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