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

Preterm Premature Rupture of Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963465
• Other study ID #: 6229
• Status: Recruiting
• Start date: September 17, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2023
• Source: Albany Medical College
• Contact: OBGYN Research Director
• Phone: 518-262-4942
• Email: Obgynresearch[@]amc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amniotic Fluid Leakage
• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membrane
• Rupture

Intervention

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

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ferning	the presence of amniotic fluid ferning	1 minute
Primary	Ferning	the presence of amniotic fluid ferning	5 minutes
Primary	Ferning	the presence of amniotic fluid ferning	10 minutes
Primary	Ferning	the presence of amniotic fluid ferning	15 minutes
Primary	Ferning	the presence of amniotic fluid ferning	20 minutes