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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00701350
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : July 21, 2010
Obstetrix Medical Group
Information provided by:
ProteoGenix, Inc.

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)

Condition or disease
Intra-amniotic Infection Preterm Birth

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). 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.

Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of Proteomic Markers of Intra-amniotic Infection (IAI) in Patients With Preterm Premature Rupture of Amniotic Membranes (PPROM)
Study Start Date : June 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Women presenting with preterm gestation and ruptured membranes

Primary Outcome Measures :
  1. Expression of protein biomarkers in cervial vaginal fluid [ Time Frame: 24 hours of amniotic membrane rupture to delivery ]

Biospecimen Retention:   Samples Without DNA
Cervical-vaginal Fluid, Amniotic Fluid, Maternal Serum, Neonatal Cord Blood, Placental and Umbilical Cord Tissues

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00701350

United States, Arizona
Banner Good Samaritan Hospital
Phoenix, Arizona, United States, 85006
Tucson Medical Center
Tucson, Arizona, United States, 85712
United States, California
Good Samaritan Hospital
San Jose, California, United States, 95008
United States, Colorado
Presbyterian St. Luke's Medical Center
Denver, Colorado, United States, 80218
Sponsors and Collaborators
ProteoGenix, Inc.
Obstetrix Medical Group
Principal Investigator: Richard Porecco, MD Obstetrix Medical Group

Responsible Party: Durlin Hickok, MD, MPH; Chief Medical Officer, ProteoGenix Identifier: NCT00701350     History of Changes
Other Study ID Numbers: PGX03-OBX0009
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: July 21, 2010
Last Verified: July 2010

Keywords provided by ProteoGenix, Inc.:
Intra-amniotic Infection
Preterm Birth
Preterm Premature Rupture of Membranes

Additional relevant MeSH terms:
Communicable Diseases
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications