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The Accuracy of Amniotic Fluid Ferning in the Second Trimester in the Diagnosis of Preterm Prelabor Rupture of Membranes

NCT04963465 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-04-18

No results posted yet for this study

Summary

Although much investigation has been done on the use of ferning in the second and third trimesters, particularly with the development of rapid protein clinical assays, there appears to be lower ferning rates in clinical practice with traditional techniques compared to previous published research on the subject. Much of the older study designs are lacking in detail and lack a large enough sample sizes at each gestational age to appropriately interpret the significance of ferning results by gestational age. Additionally, a large premise for the current tests used to diagnose rupture of membranes is based on these older studies. Given this, we propose collecting amniotic fluid vaginally to evaluate for the presence of ferning in the second trimester to determine if there is a difference in ferning based on gestational age as well as the time interval after rupture of membranes in which ferning can observed on microscope examination.

Conditions

  • Preterm Premature Rupture of Membrane
  • Amniotic Fluid Leakage

Interventions

DIAGNOSTIC_TEST

Ferning on microscopy

Amniotic fluid ferning will be assessed in the cohort before known rupture of membranes and after known rupture of membranes

Sponsors & Collaborators

  • Albany Medical College

    lead OTHER

Principal Investigators

  • OBGYN Research Director · Albany Medical College

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-17
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • United States

Study Locations

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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 NCT04963465 on ClinicalTrials.gov