Status:
WITHDRAWN
VF Test for Prediction of Extremely PTB After Cerclage
Lead Sponsor:
Pediatrix
Collaborating Sponsors:
Hologic, Inc.
Conditions:
Preterm Birth
Infection
Eligibility:
FEMALE
18+ years
Brief Summary
The purpose of this research study is to determine if a vaginal fluid (VF) test can predict very early preterm birth in patients who are scheduled to have an exam indicated cerclage for severe cervica...
Detailed Description
The purpose of this research study is to determine if a vaginal fluid (VF) test can predict very early preterm birth in patients who are scheduled to have an exam indicated cerclage for severe cervica...
Eligibility Criteria
Inclusion
- Participant age 18 years or older
- Gestational age between 16w0d to 25w6d
- Singleton fetus with no apparent major anomalies on ultrasound exam
- Sonographically absent cervical length and/or sterile digital exam of 2cm or greater dilation
- Exam-indicated cervical cerclage has been recommended by clinician and patient agrees to proceed with cervical cerclage placement
- Decision has been made by provider to perform pre-cerclage amniocentesis to rule-out infection, with the understanding that cerclage is contraindicated if findings indicate probable or definitive infection, and patient agrees.
Exclusion
- Planned termination of pregnancy
- Clinical features consistent with placental abruption or chorioamnionitis
- Need for immediate delivery based on maternal or fetal issues
- Fetus with ultrasound-determined major congenital anomalies
- Multiple gestation
- Rupture of membranes
- Patient does not give consent to participate in this study
Key Trial Info
Start Date :
June 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03443154
Start Date
June 1 2018
End Date
June 1 2018
Last Update
June 27 2018
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