A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor
NCT ID: NCT02787213
Last Updated: 2021-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5011 participants
OBSERVATIONAL
2016-08-31
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Women with preterm delivery
No interventions assigned to this group
Women without preterm delivery
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject has singleton gestation
* Subject is able to provide consent
* Gestational age is confirmed by a documented crown rump length on an ultrasound performed at the study site within 6 0/7 weeks and 13 6/7 weeks gestation (first trimester)
* Subject has no signs and/or symptoms of preterm labor and has intact membranes
* Investigator believes subject is willing to comply with study visits and procedures
* Investigator believes the subject's delivery data will be available within 15 business days from delivery, and neonatal data will be available for data collection purposes within 15 business days from discharge
Exclusion Criteria
* The subject has a planned cerclage placement for the current pregnancy
* There is a known or suspected fetal anomaly or chromosomal abnormality
* The subject has had a blood transfusion during the current pregnancy
* The subject has known elevated bilirubin levels (hyperbilirubinemia)
* The subject has taken or plans to take any of the following medications during the current pregnancy:
* Progesterone or progesterone-derivative medication after 13 6/7 weeks gestation
* Enoxaparin, heparin, heparin sodium, low molecular weight heparin after first day of last menstrual period
* The subject has participated in, or plans to participate in, an interventional treatment study during the current pregnancy
* The current pregnancy was previously a multiple gestation that is now a single fetus due to reduction, vanishing twin, etc.
18 Years
55 Years
FEMALE
No
Sponsors
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Sera Prognostics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Durlin E Hickok, MD
Role: STUDY_CHAIR
Sera Prognostics
Locations
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Maricopa Integrated Health Systems
Phoenix, Arizona, United States
University of California, Irvine Medical Center
Orange, California, United States
UC San Diego Health
San Diego, California, United States
University of Colorado-Denver
Aurora, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Oregon Health & Sciences University
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Greenville Health System
Greenville, South Carolina, United States
Regional Obstetrical Consultants
Chattanooga, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
Countries
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References
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Saade GR, Boggess KA, Sullivan SA, Markenson GR, Iams JD, Coonrod DV, Pereira LM, Esplin MS, Cousins LM, Lam GK, Hoffman MK, Severinsen RD, Pugmire T, Flick JS, Fox AC, Lueth AJ, Rust SR, Mazzola E, Hsu C, Dufford MT, Bradford CL, Ichetovkin IE, Fleischer TC, Polpitiya AD, Critchfield GC, Kearney PE, Boniface JJ, Hickok DE. Development and validation of a spontaneous preterm delivery predictor in asymptomatic women. Am J Obstet Gynecol. 2016 May;214(5):633.e1-633.e24. doi: 10.1016/j.ajog.2016.02.001. Epub 2016 Feb 11.
Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, Adler A, Vera Garcia C, Rohde S, Say L, Lawn JE. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012 Jun 9;379(9832):2162-72. doi: 10.1016/S0140-6736(12)60820-4.
Goldenberg RL, Rouse DJ. Prevention of premature birth. N Engl J Med. 1998 Jul 30;339(5):313-20. doi: 10.1056/NEJM199807303390506. No abstract available.
Rush RW, Keirse MJ, Howat P, Baum JD, Anderson AB, Turnbull AC. Contribution of preterm delivery to perinatal mortality. Br Med J. 1976 Oct 23;2(6042):965-8. doi: 10.1136/bmj.2.6042.965.
Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
Gravett MG, Novy MJ, Rosenfeld RG, Reddy AP, Jacob T, Turner M, McCormack A, Lapidus JA, Hitti J, Eschenbach DA, Roberts CT Jr, Nagalla SR. Diagnosis of intra-amniotic infection by proteomic profiling and identification of novel biomarkers. JAMA. 2004 Jul 28;292(4):462-9. doi: 10.1001/jama.292.4.462.
Ruetschi U, Rosen A, Karlsson G, Zetterberg H, Rymo L, Hagberg H, Jacobsson B. Proteomic analysis using protein chips to detect biomarkers in cervical and amniotic fluid in women with intra-amniotic inflammation. J Proteome Res. 2005 Nov-Dec;4(6):2236-42. doi: 10.1021/pr050139e.
Buhimschi CS, Bhandari V, Hamar BD, Bahtiyar MO, Zhao G, Sfakianaki AK, Pettker CM, Magloire L, Funai E, Norwitz ER, Paidas M, Copel JA, Weiner CP, Lockwood CJ, Buhimschi IA. Proteomic profiling of the amniotic fluid to detect inflammation, infection, and neonatal sepsis. PLoS Med. 2007 Jan;4(1):e18. doi: 10.1371/journal.pmed.0040018.
Gravett MG, Thomas A, Schneider KA, Reddy AP, Dasari S, Jacob T, Lu X, Rodland M, Pereira L, Sadowsky DW, Roberts CT Jr, Novy MJ, Nagalla SR. Proteomic analysis of cervical-vaginal fluid: identification of novel biomarkers for detection of intra-amniotic infection. J Proteome Res. 2007 Jan;6(1):89-96. doi: 10.1021/pr060149v.
Pereira L, Reddy AP, Jacob T, Thomas A, Schneider KA, Dasari S, Lapidus JA, Lu X, Rodland M, Roberts CT Jr, Gravett MG, Nagalla SR. Identification of novel protein biomarkers of preterm birth in human cervical-vaginal fluid. J Proteome Res. 2007 Apr;6(4):1269-76. doi: 10.1021/pr0605421. Epub 2007 Mar 21.
Esplin MS, Merrell K, Goldenberg R, Lai Y, Iams JD, Mercer B, Spong CY, Miodovnik M, Simhan HN, van Dorsten P, Dombrowski M; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Proteomic identification of serum peptides predicting subsequent spontaneous preterm birth. Am J Obstet Gynecol. 2011 May;204(5):391.e1-8. doi: 10.1016/j.ajog.2010.09.021. Epub 2010 Nov 11.
Committee opinion no 611: method for estimating due date. Obstet Gynecol. 2014 Oct;124(4):863-866. doi: 10.1097/01.AOG.0000454932.15177.be.
Hanley JA, McNeil BJ. A method of comparing the areas under receiver operating characteristic curves derived from the same cases. Radiology. 1983 Sep;148(3):839-43. doi: 10.1148/radiology.148.3.6878708.
Obuchowski NA, McClish DK. Sample size determination for diagnostic accuracy studies involving binormal ROC curve indices. Stat Med. 1997 Jul 15;16(13):1529-42. doi: 10.1002/(sici)1097-0258(19970715)16:133.0.co;2-h.
Buhimschi IA, Christner R, Buhimschi CS. Proteomic biomarker analysis of amniotic fluid for identification of intra-amniotic inflammation. BJOG. 2005 Feb;112(2):173-81. doi: 10.1111/j.1471-0528.2004.00340.x.
Markenson GR, Saade GR, Laurent LC, Heyborne KD, Coonrod DV, Schoen CN, Baxter JK, Haas DM, Longo S, Grobman WA, Sullivan SA, Major CA, Wheeler SM, Pereira LM, Su EJ, Boggess KA, Hawk AF, Crockett AH, Fox AC, Polpitiya A, Fleischer TC, Critchfield GC, Burchard J, Boniface JJ, Lam GK. Performance of a proteomic preterm delivery predictor in a large independent prospective cohort. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100140. doi: 10.1016/j.ajogmf.2020.100140. Epub 2020 May 17.
Other Identifiers
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SP 014
Identifier Type: -
Identifier Source: org_study_id
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