Preterm Birth Clinical Trial
— PPROMOfficial title:
Identification of Proteomic Markers of Intra-amniotic Infection (IAI) in Patients With Preterm Premature Rupture of Amniotic Membranes (PPROM)
Verified date | July 2010 |
Source | ProteoGenix, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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)
Status | Completed |
Enrollment | 79 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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: 1. Postive pooling, 2. Presence of ferning from cervical vaginal fluid swab on an air dried slide, 3. Postivie nitrizine pH test, or, in lieu of the criteria listed above 4. Positive Amnisure test result 5. 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: 1. Absence of labor (defined by absence of painful uterine contractions) 2. No clinical signs of infection (maternal fever of 37.9 C or greater, fetal heart rate greater than 160 bpm, uterine tenderness, purulent aminorrhea) 3. presence of non-reassuring heart tracing - Subject is a candidate for amniocentesis as evidenced by the following: 1. Ultrasound reveals pocket of fluid likely to result in successful amniocentesis 2. 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 Criteria: - 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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Presbyterian St. Luke's Medical Center | Denver | Colorado |
United States | Banner Good Samaritan Hospital | Phoenix | Arizona |
United States | Good Samaritan Hospital | San Jose | California |
United States | Tucson Medical Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
ProteoGenix, Inc. | Obstetrix Medical Group |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Expression of protein biomarkers in cervial vaginal fluid | 24 hours of amniotic membrane rupture to delivery | No |
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