NCT04963465

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
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Albany Medical College · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Premature Rupture of Membrane
• Amniotic Fluid Leakage

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ferning on microscopy	Amniotic fluid ferning will be assessed in the cohort before known rupture of membranes and after known rupture of membranes

Timeline

• Start date: 2021-09-17
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-07-15
• Last updated: 2023-04-18

Locations

1 site across 1 country: United States