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

Intra-amniotic Infection Clinical Trial

— IAI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00700219
• Other study ID #: PGX01-OBX0006
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2008
• Last updated: July 19, 2010
• Start date: June 2008
• Est. completion date: September 2010

Study information

• Verified date: July 2010
• Source: ProteoGenix, Inc.
• Contact: Desiree Hollemon, MSN, MPH
• Phone: 503-748-4067
• Email: hollemon[@]proteogenix.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Intra-amniotic Infection
• Obstetric Labor, Premature

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey
United States	Carolinas Medical Center /Dept. OB/GYN	Charlotte	North Carolina
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Greater Cincinnati Medical Center	Cincinnati	Ohio
United States	Presbyterian St. Luke's Medical Center	Denver	Colorado
United States	Swedish Medical Center	Englewood	Colorado
United States	UMCG Dept of OB/GYN	Greenville	South Carolina
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Long Beach Memorial Hospital	Long Beach	California
United States	Norton Downtown	Louisville	Kentucky
United States	Banner Desert Memorial Medical Center	Mesa	Arizona
United States	Mount Sinai School of Medicine	NYC	New York
United States	Thomas Jefferson University Medical Center	Philadelphia	Pennsylvania
United States	Banner Good Samaritan Hospital	Phoenix	Arizona
United States	University of Pittsburgh, Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Good Samaritan Hospital	San Jose	California
United States	Swedish Medical Center	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	St. Louis University School of Medicine	St. Louis	Missouri
United States	Tucson Medical Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
ProteoGenix, Inc.	Obstetrix Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of immunoassay panel to detect intra-amniotic infection in target population.		Presentation to delivery	No