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

Completed

Conditions studied: Intra-amniotic Infection, Preterm Birth

In brief

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)

Key facts

Study ID

NCT00701350

Run by

ProteoGenix, Inc.

People needed

79

Starts

2008-06-01

Expected to finish

2010-02-01

Last updated by the study team

2010-07-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject is 18 years of age or older
• Subject has singleton gestation
• Subject has fetus with getstational age of at least 23 0/7 days and no greater than 33 6/7 days
• Subject has diagnosis of preterm premature rupture of amniotic membranes as determined by at least two of the following:
• 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
• Subject is enrolled and has an amniocentesis within 24 hours of membrane rupture
• Subject is a candidate for expectant management as evidenced by the following:
• 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
• Subject is a candidate for amniocentesis as evidenced by the following:
• Ultrasound reveals pocket of fluid likely to result in successful amniocentesis
• Physician believes that the subject shoudl undergo amniocentesis as part of their routine evaluation of their current problem of PPROM to rule out infection and/or to test for lung maturity

You may not qualify if…

• Subject has a fetus with major fetal anomaly (life threatening or requires surgical intervention) or chromosomal aneuploidy
• Subject has pre-existing medical indication for preterm delivery (e.g., pre-eclampsia, refractory hypertension, diabetes with significant complications, active lupus)
• Subject is unable to provide informed consent

Where it is running

• Banner Good Samaritan Hospital — Phoenix, Arizona, United States
• Tucson Medical Center — Tucson, Arizona, United States
• Good Samaritan Hospital — San Jose, California, United States
• Presbyterian St. Luke's Medical Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.