Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes (IAI)
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ClinicalTrials.gov 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
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Tracking Information | ||||
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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 |
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. |
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Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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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 |
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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 |
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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. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | ProteoGenix, Inc. | |||
Verification Date | July 2010 |