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

Phase 2

• Conditions: Amniotic Fluid Leakage
• Interventions: Device: BirthSign

• Registration Number: NCT01517633
• Lead Sponsor: Hadassah Medical Organization

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.

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.

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-24
• Last Update Submitted: 2012-01-24
• Study First Posted: 2012-01-25
• Last Update Posted: 2012-01-25
• Primary Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A device for identifying between amniotic fluid and urine	BirthSign	-

Primary Outcome Measures

Name	Time	Method
Presence / absence of stains comparing to a known color index printed on the product	12 hours	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

Name	Time	Method
Presence / absence of stains comparing to a known color index printed on the product	12 hours	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.

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel