Recruiting

Amniotic Fluid Ferning

Sponsor:

Albany Medical College

Code:

NCT04963465

Conditions

Preterm Premature Rupture of Membrane

Amniotic Fluid Leakage

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ferning on microscopy

Study Details

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

Study ID

NCT04963465

Start date

Sep 17, 2021

Status verified date

Apr, 2023

Completion date

Dec 1, 2023

Anticipated

Primary completion date

Dec 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Before rupture of membranes

Vaginal swab collection prior to iatrogenic rupture of membranes

After rupture of membranes

Vaginal swab collection after iatrogenic rupture of membranes

Interventions

Ferning on microscopy

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

Primary outcome measure

  • Ferning [ Time Frame: 1 minute ]
  • Ferning [ Time Frame: 5 minutes ]
  • Ferning [ Time Frame: 10 minutes ]
  • Ferning [ Time Frame: 15 minutes ]
  • Ferning [ Time Frame: 20 minutes ]

Central Contacts and Locations

Central contacts

OBGYN Research Director

518-262-4942Obgynresearch@amc.edu

Locations

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

OBGYN Research Director

518-262-4942Obgynresearch@amc.edu

More Information

Sponsor

Albany Medical College

Last update posted

Apr 18, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2023-04-18.