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Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes (IAI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by ProteoGenix, Inc..
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Obstetrix Medical Group
Information provided by:
ProteoGenix, Inc.
ClinicalTrials.gov Identifier:
NCT00700219
First received: June 13, 2008
Last updated: July 19, 2010
Last verified: July 2010
  Purpose
The purpose of this study is to collect clinical specimens and corresponding clinical data to develop a non-invasive test for detection of intra-amniotic infection and prediction of preterm birth in women and intact amniotic membranes. The specimens collected will be used to develop a specific biomarker panel and algorithm using immunoassays for optimal detection of intra-amniotic infection in women with preterm labor and intact amniotic membranes.

Condition
Intra-amniotic Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Non-invasive Test to Detect Intra-amniotic Infection and Predict Preterm Birth in Women Presenting With Preterm Labor and and Intact Amniotic Membranes

Further study details as provided by ProteoGenix, Inc.:

Primary Outcome Measures:
  • Performance of immunoassay panel to detect intra-amniotic infection in target population. [ Time Frame: Presentation to delivery ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 900
Study Start Date: June 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Women presenting in preterm labor with intact amniotic membranes

Detailed Description:

Intra-amniotic infection (IAI) is an acute bacterial infection of the amniotic fluid and intrauterine contents during pregnancy and occurs in 4% to 10% of all deliveries (Newton, ER., 1993. Newton, ER, et al., 1989. Soper, DE, et al., 1989). IAI is an important cause of maternal and neonatal morbidity. Identifying and appropriately treating women with IAI is, therefore, a major obstetrical challenge.

Intrauterine infection may occur early in pregnancy and remain undetected for a prolonged period, thus exposing the fetus to the effects of infection/inflammation for a considerable period. Ideally, an early diagnosis of IAI is important to allow timely treatment and intervention. Unfortunately, the early diagnosis is difficult because the clinical signs and symptoms of IAI may occur late in the course of the infection and are neither sensitive nor specific. Therefore, to avoid a delay in diagnosis a high degree of suspicion and the appropriate use of adjunctive laboratory tests are warranted.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women presenting to labor and delivery with signs and symptoms of preterm labor and documented intact amntiotic membranes
Criteria

Inclusion Criteria:

  • Subject is greater than or equal to 18 years of age
  • Subject has singleton gestation
  • Subject has fetus with gestational age greater than or equal to 22 0/7 weeks and less than or equal to 36 6/7 weeks
  • Subject has documented intact amniotic membranes
  • Subject's care provider plans to or has performed an amniocentesis procedure
  • Subject has had evidence of spontaneous preterm labor as evidenced by documented regular uterine contractions (greater than or equal to four per hour, or if less than 26 weeks gestation, cramping or backache) and one or more of the following:

    1. Progressive cervical change with cervical dilation of greater than or equal to 2 cm
    2. Effacement of greater than or equal to 50%
    3. Cervical length of less than or equal to 30 mm via transvaginal ultrasound
    4. Positive fetal fibronectin test

Exclusion Criteria:

  • Subject has documented ruptured amniotic membranes
  • Subject has fetus with major fetal anomaly or chromosomal aneuploidy
  • Subject has medical indication for preterm birth (e.g. pre-eclampsia)
  • Subject is unable to provide written informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700219

Locations
United States, Arizona
Banner Desert Memorial Medical Center
Mesa, Arizona, United States, 85202
Banner Good Samaritan Hospital
Phoenix, Arizona, United States, 85006
Tucson Medical Center
Tucson, Arizona, United States, 85712
United States, California
Long Beach Memorial Hospital
Long Beach, California, United States, 90801
Good Samaritan Hospital
San Jose, California, United States, 95008
United States, Colorado
Presbyterian St. Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Norton Downtown
Louisville, Kentucky, United States, 40202
United States, Missouri
St. Louis University School of Medicine
St. Louis, Missouri, United States, 63117
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
Mount Sinai School of Medicine
NYC, New York, United States, 10029
United States, North Carolina
Carolinas Medical Center /Dept. OB/GYN
Charlotte, North Carolina, United States, 28203
United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Greater Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Thomas Jefferson University Medical Center
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh, Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
UMCG Dept of OB/GYN
Greenville, South Carolina, United States, 29605
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Sponsors and Collaborators
ProteoGenix, Inc.
Obstetrix Medical Group
Investigators
Principal Investigator: Andrew Combs, MD, PhD Obstetrix Medical Group of California
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Durlin Hickok, MD, MPH, ProteoGenix, Inc.
ClinicalTrials.gov Identifier: NCT00700219     History of Changes
Other Study ID Numbers: PGX01-OBX0006 
Study First Received: June 13, 2008
Last Updated: July 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by ProteoGenix, Inc.:
Preterm Labor
Preterm Birth
Intra-amniotic Infection
Pregnancy
Women

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

ClinicalTrials.gov processed this record on December 07, 2016