CompletedNot Applicable

Biomarkers of Intra-amniotic Infection in Women With Preterm Premature Ruptured Amniotic Membranes

United States79 participantsStarted 2008-06

Plain-language summary

The purpose of this study is to investigate the expression of protein biomarkers in cervical vaginal fluid in women with preterm premature rupture of membranes (PPROM)

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Postive pooling,
✓. Presence of ferning from cervical vaginal fluid swab on an air dried slide,
✓. Postivie nitrizine pH test, or, in lieu of the criteria listed above
✓. Positive Amnisure test result
✓. Positive indigo carmine egress vaginally following instillation at amniocentesis
✓. Absence of labor (defined by absence of painful uterine contractions)
✓. No clinical signs of infection (maternal fever of 37.9 C or greater, fetal heart rate greater than 160 bpm, uterine tenderness, purulent aminorrhea)
✓. presence of non-reassuring heart tracing

What they're measuring

Expression of protein biomarkers in cervial vaginal fluid

Timeframe: 24 hours of amniotic membrane rupture to delivery

Trial details

NCT IDNCT00701350

SponsorProteoGenix, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-02

View on ClinicalTrials.gov More Intra-amniotic Infection trials