Clinical trial NCT00700219: Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intra-amniotic Infection
Keywords: Preterm Labor
Preterm Birth
Intra-amniotic Infection
Pregnancy
Women
Lead sponsor: ProteoGenix, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Obstetrix Medical Group
First posted: 2008-06-18
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: Performance of immunoassay panel to detect intra-amniotic infection in target population.
timeFrame: Presentation to delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Banner Desert Memorial Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Banner Good Samaritan Hospital
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Long Beach
country: United States
facility: Long Beach Memorial Hospital
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Denver
country: United States
facility: Presbyterian St. Luke's Medical Center
state: Colorado
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Louisville
country: United States
facility: Norton Downtown
state: Kentucky
city: St. Louis
country: United States
facility: St. Louis University School of Medicine
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: NYC
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center /Dept. OB/GYN
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Greater Cincinnati Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Magee Womens Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: UMCG Dept of OB/GYN
state: South Carolina
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Obstetrix Medical Group of California
name: Andrew Combs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.