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VF Test for Prediction of Extremely PTB After Cerclage

NCT03443154 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-06-27

No results posted yet for this study

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 cervical shortening.

Prior to participants undergoing a scheduled amniocentesis two swabs to collect vaginal secretions for the VF tests will be done. During the amniocentesis your doctor will remove amniotic fluid as part of the routine clinical care. From that fluid sample, the study will use less than a quarter teaspoon for the amniotic fluid study test (AF test). Data regarding maternal and birth outcomes will be collected by medical record review.

Conditions

Interventions

DIAGNOSTIC_TEST

VF-Test

A vaginal fluid test of interleukin-6 (IL-6) and alphafetoprotein (AFP).

Sponsors & Collaborators

  • Hologic, Inc.

    collaborator INDUSTRY

  • Pediatrix

    lead OTHER

Principal Investigators

  • Jeroen Vanderhoeven, MD · Pediatrix

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2018-06-01
Completion
2018-06-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03443154 on ClinicalTrials.gov