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 range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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