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

Recruiting

• Conditions: Preterm Premature Rupture of Membrane; Amniotic Fluid Leakage
• Interventions: Diagnostic Test: Ferning on microscopy

• Registration Number: NCT04963465
• Lead Sponsor: Albany Medical College

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-15
• Study Start: 2021-09-17
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
After rupture of membranes	Ferning on microscopy	Vaginal swab collection after iatrogenic rupture of membranes
Before rupture of membranes	Ferning on microscopy	Vaginal swab collection prior to iatrogenic rupture of membranes

Primary Outcome Measures

Name	Time	Method
Ferning	20 minutes	the presence of amniotic fluid ferning

Trial Locations

Locations (1)

Albany Medical Center; 🇺🇸 Albany, New York, United States