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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04963465
Enrollment
100
Registered
2021-07-15
Start date
2021-09-17
Completion date
2023-12-01
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amniotic Fluid Leakage, Preterm Premature Rupture of Membrane

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.

Interventions

DIAGNOSTIC_TESTFerning on microscopy

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

Sponsors

Albany Medical College
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ferning1 minutethe presence of amniotic fluid ferning

Countries

United States

Contacts

Primary ContactOBGYN Research Director
Obgynresearch@amc.edu518-262-4942

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026