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

Recruiting
Conditions
Preterm Premature Rupture of Membrane
Amniotic Fluid Leakage
Registration Number
NCT04963465
Lead Sponsor
Albany Medical College
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
100
Inclusion Criteria
  • 18 years or older
  • English speaking
  • singleton or multi fetal gestation
  • between 15 and 24 weeks gestation
  • undergoing elective pregnancy termination
Exclusion Criteria
  • known rupture of membranes or anhydramnios

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Ferning20 minutes

the presence of amniotic fluid ferning

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Albany Medical Center

🇺🇸

Albany, New York, United States

Albany Medical Center
🇺🇸Albany, New York, United States
OBGYN Research Director
Contact
518-262-4942
Obgynresearch@amc.edu
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