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

Amniotic Fluid Leakage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01517633
• Other study ID #: 300165-HMO-CTIL
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: January 23, 2012
• Last updated: January 24, 2012
• Start date: January 2012

Study information

• Verified date: January 2012
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Amniotic Fluid Leakage

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & 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):561-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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 clinician and a measurement of patient comfort while using the device, reading the results and clarity of instructions.	12 hours	No