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

Hadassah Medical Center

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Amniotic Fluid Leakage

Treatments: Device: BirthSign

Study type: Interventional

Funder types: Other

Identifiers

NCT01517633

300165-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

A device for identifying between amniotic fluid and urine

Experimental group

Treatment:

Device: BirthSign