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

NCT04963465 | Unknown

• 1 other identifier: 6229
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Premature Rupture of Membrane; Amniotic Fluid Leakage

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Before rupture of membranes

Vaginal swab collection prior to iatrogenic rupture of membranes

Diagnostic Test: Ferning on microscopy

After rupture of membranes

Vaginal swab collection after iatrogenic rupture of membranes

Diagnostic Test: Ferning on microscopy

Interventions

Ferning on microscopy DIAGNOSTIC_TEST

Amniotic fluid ferning will be assessed in the cohort before known rupture of membranes and after known rupture of membranes

After rupture of membranes; Before rupture of membranes

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years or older
• English speaking
• singleton or multi fetal gestation
• between 15 and 24 weeks gestation
• undergoing elective pregnancy termination

You may not qualify if:

• known rupture of membranes or anhydramnios

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Study Officials

• OBGYN Research Director

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

OBGYN Research Director

CONTACT

518-262-4942; Obgynresearch@amc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 15, 2021
• Study Start: September 17, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)