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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Premature Rupture of Membrane; Amniotic Fluid Leakage
• Intervention / Treatment: Diagnostic test: Ferning on microscopy

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: OBGYN Research Director; Phone Number: 518-262-4942; Email: Obgynresearch@amc.edu

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical Center
      • Contact: OBGYN Research Director; Phone Number: 518-262-4942; Email: Obgynresearch@amc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Prospective observational study including pregnant women 18 years or older who present for pregnancy termination, between 15 and 24 weeks gestation. Women with a singleton or multi-fetal gestation, who have previously established dating based on a first trimester ultrasound or ultrasound prior to 22 weeks gestation, will be included. Exclusion criterion are women who are less than 18 years of age, non-English speaking, and rupture of membranes or anhydramnios (no measurable amniotic fluid on ultrasound) at the time of data collection in the operating room.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before rupture of membranes; Vaginal swab collection prior to iatrogenic rupture of membranes	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
After rupture of membranes; Vaginal swab collection after iatrogenic rupture of membranes	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ferning	the presence of amniotic fluid ferning	1 minute
Ferning	the presence of amniotic fluid ferning	5 minutes
Ferning	the presence of amniotic fluid ferning	10 minutes
Ferning	the presence of amniotic fluid ferning	15 minutes
Ferning	the presence of amniotic fluid ferning	20 minutes

Collaborators and Investigators

• Sponsor: Albany Medical College
• Investigators: Principal Investigator: OBGYN Research Director, Albany Medical College

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Rupture; Premature Birth; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: 6229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No