Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine

NCT01517633 | Unknown Phase 2

• 1 other identifier: 300165-HMO-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the reliability and validity of a new device with standard methods for diagnosing between amniotic fluid leakage due to premature rupture of the membranes (PROM) and urine.

Conditions

Amniotic Fluid Leakage

Keywords

Amniotic fluid leakage; Urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Presence / absence of stains comparing to a known color index printed on the product

  Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the woman.

  12 hours

Secondary Outcomes (1)

• Presence / absence of stains comparing to a known color index printed on the product

  12 hours

Study Arms (1)

A device for identifying between amniotic fluid and urine

EXPERIMENTAL

Device: BirthSign

Interventions

BirthSign DEVICE

When leakage from the vagina occurs, the woman will wet the indicator lines of the device with the body fluids.

A device for identifying between amniotic fluid and urine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women age 18 years and older attending delivery room.
• Stage of gestation: pregnancy between 16 and 42 weeks of gestation.
• Able and willing to read and sign an informed consent document.

You may not qualify if:

• Subjects will be excluded from the study if any of the following will be present:
• Prior use of any amniotic fluid detection test.
• Use of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours.
• Vaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours.
• Sexual intercourse within the past 24 hours.
• Confirmed diagnosis of any vaginal infection within the past 7 days.
• Use of vaginal products or antibiotic treatments that reduce bacterial population or use of medications such as tamoxifen that reduce estrogen levels or antihistamines that dry mucous membranes within the past 7 days..
• Patients unable or unwilling to participate.
• Patients in active labor (or with regular contractions).

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Related Publications (1)

• El-Messidi A, Cameron A. Diagnosis of premature rupture of membranes: inspiration from the past and insights for the future. J Obstet Gynaecol Can. 2010 Jun;32(6):561-569. doi: 10.1016/S1701-2163(16)34525-X.

  PMID: 20569537 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 25, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Last Updated: January 25, 2012

Record last verified: 2012-01

Locations

IL (1)