Last reviewed · How we verify

NCT04963465

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

Status unknown Last updated 18 April 2023
What this trial tests

trial testing Ferning on microscopy in Preterm Premature Rupture of Membrane in 100 participants. Status unknown.

Timeline
17 September 2021
Primary endpoint
1 December 2023
1 December 2023

Quick facts

Lead sponsorAlbany Medical College
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment100
Start date17 September 2021
Primary completion1 December 2023
Estimated completion1 December 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Albany Medical College

Who can join

18 and older, female only, with Preterm Premature Rupture of Membrane or Amniotic Fluid Leakage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Preterm Premature Rupture of Membrane

Currently open trials in the same condition.

Other Albany Medical College trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04963465.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing