NCT01517633

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Amniotic Fluid Leakage

Interventions

Type	Name	Description
DEVICE	BirthSign	When leakage from the vagina occurs, the woman will wet the indicator lines of the device with the body fluids.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-01-01
• First posted: 2012-01-25
• Last updated: 2012-01-25

Locations

1 site across 1 country: Israel