Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

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.

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.

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