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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-17

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Preterm Premature Rupture of Membrane Amniotic Fluid Leakage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Before rupture of membranes

Vaginal swab collection prior to iatrogenic rupture of membranes

Ferning on microscopy

Intervention Type DIAGNOSTIC_TEST

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

After rupture of membranes

Vaginal swab collection after iatrogenic rupture of membranes

Ferning on microscopy

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Ferning on microscopy

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* English speaking
* singleton or multi fetal gestation
* between 15 and 24 weeks gestation
* undergoing elective pregnancy termination