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

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: NCT00700219
Recruitment Status : Unknown
Verified July 2010 by ProteoGenix, Inc..
Recruitment status was:  Recruiting
First Posted : June 18, 2008
Last Update Posted : July 21, 2010
Obstetrix Medical Group
Information provided by:
ProteoGenix, Inc.

June 13, 2008
June 18, 2008
July 21, 2010
June 2008
September 2010   (Final data collection date for primary outcome measure)
Performance of immunoassay panel to detect intra-amniotic infection in target population. [ Time Frame: Presentation to delivery ]
Same as current
Complete list of historical versions of study NCT00700219 on Archive Site
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Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes
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
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.

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.

Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples Without DNA
Cervical-vaginal Fluid, Amniotic Fluid, Maternal Serum, Neonatal Cord Blood, Maternal Urine, Placental and Umbilical Cord Tissues
Non-Probability Sample
Women presenting to labor and delivery with signs and symptoms of preterm labor and documented intact amntiotic membranes
Intra-amniotic Infection
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Women presenting in preterm labor with intact amniotic membranes
Combs CA, Garite TJ, Lapidus JA, Lapointe JP, Gravett M, Rael J, Amon E, Baxter JK, Brady K, Clewell W, Eddleman KA, Fortunato S, Franco A, Haas DM, Heyborne K, Hickok DE, How HY, Luthy D, Miller H, Nageotte M, Pereira L, Porreco R, Robilio PA, Simhan H, Sullivan SA, Trofatter K, Westover T; Obstetrix Collaborative Research Network. Detection of microbial invasion of the amniotic cavity by analysis of cervicovaginal proteins in women with preterm labor and intact membranes. Am J Obstet Gynecol. 2015 Apr;212(4):482.e1-482.e12. doi: 10.1016/j.ajog.2015.02.007. Epub 2015 Feb 14.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
September 2010
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Durlin Hickok, MD, MPH, ProteoGenix, Inc.
ProteoGenix, Inc.
Obstetrix Medical Group
Principal Investigator: Andrew Combs, MD, PhD Obstetrix Medical Group of California
ProteoGenix, Inc.
July 2010