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

• Conditions: Intra-amniotic Infection

• Registration Number: NCT00700219
• Lead Sponsor: ProteoGenix, Inc.

Brief Summary

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.

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-19
• Last Update Posted: 2010-07-21
• Primary Completion: 2010-09
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of immunoassay panel to detect intra-amniotic infection in target population.	Presentation to delivery

Trial Locations

Locations (19)

Banner Desert Memorial Medical Center; 🇺🇸 Mesa, Arizona, United States

Banner Good Samaritan Hospital; 🇺🇸 Phoenix, Arizona, United States

Tucson Medical Center; 🇺🇸 Tucson, Arizona, United States

Long Beach Memorial Hospital; 🇺🇸 Long Beach, California, United States

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States

Presbyterian St. Luke's Medical Center; 🇺🇸 Denver, Colorado, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Norton Downtown; 🇺🇸 Louisville, Kentucky, United States

St. Louis University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

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