Status:
UNKNOWN
Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Amniotic Fluid Leakage
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
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...
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 incontinenc...
Eligibility Criteria
Inclusion
- Pregnant women age 18 years and older attending delivery room.
- Stage of gestation: pregnancy between 16 and 42 weeks of gestation.
- Able and willing to read and sign an informed consent document.
Exclusion
- Subjects will be excluded from the study if any of the following will be present:
- Prior use of any amniotic fluid detection test.
- Use of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours.
- Vaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours.
- Sexual intercourse within the past 24 hours.
- Confirmed diagnosis of any vaginal infection within the past 7 days.
- 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..
- Patients unable or unwilling to participate.
- Patients in active labor (or with regular contractions).
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01517633
Start Date
January 1 2012
Last Update
January 25 2012
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120