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

Tracking Information
First Submitted Date	June 13, 2008
First Posted Date	June 18, 2008
Last Update Posted Date	July 21, 2010
Study Start Date	June 2008
Estimated Primary Completion Date	September 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: June 17, 2008)	Performance of immunoassay panel to detect intra-amniotic infection in target population. [ Time Frame: Presentation to delivery ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT00700219 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	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
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 Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA; Description: Cervical-vaginal Fluid, Amniotic Fluid, Maternal Serum, Neonatal Cord Blood, Maternal Urine, Placental and Umbilical Cord Tissues
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
Condition	Intra-amniotic Infection
Intervention	Not Provided
Study Groups/Cohorts	1; Women presenting in preterm labor with intact amniotic membranes
Publications *	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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Estimated Enrollment; (submitted: June 17, 2008)	900
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	September 2010
Estimated Primary Completion Date	September 2010 (Final data collection date for primary outcome measure)
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: Progressive cervical change with cervical dilation of greater than or equal to 2 cm Effacement of greater than or equal to 50% Cervical length of less than or equal to 30 mm via transvaginal ultrasound 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
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00700219
Other Study ID Numbers	PGX01-OBX0006
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Durlin Hickok, MD, MPH, ProteoGenix, Inc.
Study Sponsor	ProteoGenix, Inc.
Collaborators	Obstetrix Medical Group
Investigators	Principal Investigator: Andrew Combs, MD, PhD Obstetrix Medical Group of California
PRS Account	ProteoGenix, Inc.
Verification Date	July 2010