UnknownPhase 2/3

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

Israel100 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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 criteria

✕. 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).

What they're measuring

Presence / absence of stains comparing to a known color index printed on the product

Timeframe: 12 hours

Trial details

NCT IDNCT01517633

SponsorHadassah Medical Organization

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-01

View on ClinicalTrials.gov More Amniotic Fluid Leakage trials