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Sponsors and Collaborators: |
ProteoGenix, Inc. Obstetrix Medical Group |
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Information provided by: | ProteoGenix, Inc. |
ClinicalTrials.gov Identifier: | NCT00701350 |
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)
Condition |
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Intra-Amniotic Infection Preterm Birth |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Identification of Proteomic Markers of Intra-Amniotic Infection (IAI) in Patients With Preterm Premature Rupture of Amniotic Membranes (PPROM) |
Cervical-vaginal Fluid, Amniotic Fluid, Maternal Serum, Neonatal Cord Blood, Placental and Umbilical Cord Tissues
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Women presenting with preterm gestation and ruptured membranes
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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). While there are multiple possible etiologies of PPROM, intra-amniotic infection has been implicated as a major contributor, especially at early gestational ages where fetal and neonatal adverse sequelae are frequent (Yoon, et al. 2000). Micro-organisms are recovered from the amniotic fluid obtained by trans-abdominal amniocentesis in 25-40% of women at the time of presentation with PPROM (Simhan and Canavan 2005).
Significant risks to the fetus following PPROM include both complications related to prematurity and to infection or inflammation (ACOG Practice Bulletin 2007). Complications related to prematurity include respiratory distress, intraventricular hemorrhage, and necrotizing enterocolitis. IAI, both clinically apparent and occult, is an important and potentially preventable cause of cerebral white matter injury and cerebral palsy. Ideally, an early diagnosis of IAI in the setting of PPROM is important to allow timely treatment and intervention. Amniocentesis is successful from 40 - 72% of the time with PPROM (Garite, 1982, Blackwell and Berry, 1999). Despite the accuracy for determining infection and the feasibility of amniocentesis, the vast majority of clinicians are reluctant and/or unwilling to perform this procedure in this clinical setting (Capeless and Mead, (1987). There is therefore a critical need for a noninvasive test to identify patients with IAI and PPROM. Timely identification of these sub-clinically infected patients is critical in designing rationale and efficacious treatment strategies that may reduce the fetal and neonatal sequelae associated with PPROM.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Women within the target gestational age range presenting to labor and delivery wards with documented rupture of amniotic membranes no greater than 24 hours duration.
Inclusion Criteria:
Subject has diagnosis of preterm premature rupture of amniotic membranes as determined by at least two of the following:
Subject is a candidate for expectant management as evidenced by the following:
Subject is a candidate for amniocentesis as evidenced by the following:
Exclusion Criteria:
Contact: Desiree Hollemon, MSN, MPH | 503-748-4067 | hollemon@proteogenix.com |
Contact: Durlin Hickok, MD, MPH | 503-748-4080 | hickok@proteogenix.com |
United States, Arizona | |
Banner Good Samaritan Hospital | Not yet recruiting |
Phoenix, Arizona, United States, 85006 | |
Contact: Melissa Ingersoll, BSN | |
Contact: Cathy Murray, BSN | |
Principal Investigator: William Clewell, MD | |
Tucson Medical Center | Not yet recruiting |
Tucson, Arizona, United States, 85712 | |
Contact: Diane Mercer, BSN | |
Principal Investigator: Hugh Miller, MD | |
United States, California | |
Good Samaritan Hospital | Not yet recruiting |
San Jose, California, United States, 95008 | |
Contact: Kimberly Ireland, BSN | |
Contact: Tammy Meyer, BSN | |
Principal Investigator: Andrew Combs, MD, PhD | |
United States, Colorado | |
Presbyterian St. Luke's Medical Center | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: Jeri Lech, BSN | |
Contact: Julie Rael, BSN | |
Principal Investigator: Richard Porecco, MD |
Principal Investigator: | Richard Porecco, MD | Obstetrix Medical Group |
Responsible Party: | ProteoGenix ( Durlin Hickok, MD, MPH; Chief Medical Officer ) |
Study ID Numbers: | PGX03-OBX0009 |
Study First Received: | June 13, 2008 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00701350 |
Health Authority: | United States: Institutional Review Board |
Pregnancy Intra-amniotic Infection Preterm Birth Preterm Premature Rupture of Membranes |
Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications |
Rupture Fetal Membranes, Premature Rupture Premature Birth |
Communicable Diseases Infection |