Cerclage for Prevention on Preterm Birth in Women With Placenta Previa
NCT ID: NCT01442207
Last Updated: 2014-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2012-03-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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, PROM \> 34 wks, worsening maternal or fetal condition )
* Fetal Fibronectin (fFN) test collected at the time of transvaginal Ultrasound.
Placement of 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
Placement of a Cervical Cerclage
Surgical placement of a cervical cerclage
Interventions
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Placement of a Cervical Cerclage
Surgical placement of a cervical cerclage
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, PROM \> 34 wks, worsening maternal or fetal condition )
* Fetal Fibronectin (fFN) test collected at the time of transvaginal Ultrasound.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Obstetrix Medical Group
INDUSTRY
Responsible Party
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Principal Investigators
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Irene Stafford, MD
Role: PRINCIPAL_INVESTIGATOR
Obstetrix Medical Group of Tucson.
Countries
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Other Identifiers
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OBX 0018
Identifier Type: -
Identifier Source: org_study_id