Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature Birth, Placenta Previa

Intervention / Treatment
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* Procedure: Placement of a Cervical Cerclage
* Procedure: Standard Expectant Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placement of Cervical Cerclage<br>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<br>* Surgical placement of a cervical cerclage<br>* Other names: cerclage;|
| Placebo Comparator: Expectant Management<br>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<br>* 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.<br>* Other names: Expectant Management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age (GA) at 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 | Newborn Birth weight measure within 1-2 days after birth. | measured within 1-2 days after birth | 
| Need for Maternal Blood Product replacement | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Birth, Placenta Previa