Status:
COMPLETED
Biomarkers of Intra-amniotic Infection in Women With Preterm Premature Ruptured Amniotic Membranes
Lead Sponsor:
ProteoGenix, Inc.
Collaborating Sponsors:
Obstetrix Medical Group
Conditions:
Intra-amniotic Infection
Preterm Birth
Eligibility:
FEMALE
18+ years
Brief 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)
Detailed Description
Preterm premature rupture of the membranes (PPROM) prior to 37 weeks of gestation occurs in approximately 3% of all pregnancies and is associated with one-third of all preterm births (Mercer, 2003). W...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00701350
Start Date
June 1 2008
End Date
February 1 2010
Last Update
July 21 2010
Active Locations (4)
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1
Banner Good Samaritan Hospital
Phoenix, Arizona, United States, 85006
2
Tucson Medical Center
Tucson, Arizona, United States, 85712
3
Good Samaritan Hospital
San Jose, California, United States, 95008
4
Presbyterian St. Luke's Medical Center
Denver, Colorado, United States, 80218