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

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Albany Medical College

Status

Enrolling

Conditions

Amniotic Fluid Leakage
Preterm Premature Rupture of Membrane

Treatments

Diagnostic Test: Ferning on microscopy

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Before rupture of membranes
Description:
Vaginal swab collection prior to iatrogenic rupture of membranes
Treatment:
Diagnostic Test: Ferning on microscopy
After rupture of membranes
Description:
Vaginal swab collection after iatrogenic rupture of membranes
Treatment:
Diagnostic Test: Ferning on microscopy

Trial contacts and locations

1

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Central trial contact

OBGYN Research Director

Data sourced from clinicaltrials.gov

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