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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01517633
First received: January 23, 2012
Last updated: January 24, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Amniotic Fluid Leakage
 Device: BirthSign
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Presence / absence of stains comparing to a known color index printed on the product [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the woman.


Secondary Outcome Measures:
  • Presence / absence of stains comparing to a known color index printed on the product [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the clinician and a measurement of patient comfort while using the device, reading the results and clarity of instructions.


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A device for identifying between amniotic fluid and urine Device: BirthSign
When leakage from the vagina occurs, the woman will wet the indicator lines of the device with the body fluids.

Detailed Description:

Pregnant women sensing wetness and arriving to the delivery room with suspect PROM will use a self-testing device to test whether the wetness is caused by amniotic fluid leakage or urinary incontinence. Clinical evaluation will be performed to all pregnant women using standard clinical tests. The results of the standard clinical tests will be compared to the women's reading of the self-testing device results. Sensitivity and specificity of the device evaluation will be calculated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Subjects will be excluded from the study if any of the following will be present:

  1. Prior use of any amniotic fluid detection test.
  2. Use of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours.
  3. Vaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours.
  4. Sexual intercourse within the past 24 hours.
  5. Confirmed diagnosis of any vaginal infection within the past 7 days.
  6. 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..
  7. Patients unable or unwilling to participate.
  8. Patients in active labor (or with regular contractions).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517633

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Publications:

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01517633     History of Changes
Other Study ID Numbers: 300165-HMO-CTIL
Study First Received: January 23, 2012
Last Updated: January 24, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Amniotic fluid leakage
Urinary incontinence

ClinicalTrials.gov processed this record on May 21, 2013