Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

Obstetrix Medical Group

Status and phase: Withdrawn; Phase 3

Conditions: Placenta Previa; Premature Birth

Treatments: Procedure: Placement of a Cervical Cerclage; Procedure: Standard Expectant Management

Study type: Interventional

Funder types: Industry

Identifiers

NCT01442207

OBX 0018

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Placement of Cervical Cerclage

Active Comparator group

Description:

Cervical Cerclage is to be placed in an inpatient hospital setting within 24 to 72 hours of being assigned to this treatment group

Treatment:

Procedure: Placement of a Cervical Cerclage

Expectant Management

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Standard Expectant Management