A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor

NCT02787213 | Completed DMC

• 1 other identifier: SP 014
• Study Type: observational
• Target: 5,011
• Locations: 1 country
• Sites: 18

Brief Summary

Prospective multicenter observational study to further develop and validate a preterm birth risk predictor, using a preterm cutoff at 37 0/7 weeks gestation and at 35 0/7 weeks gestation. A single maternal peripheral blood sample will be collected for analysis. Data related to potential risk factors for preterm birth will be obtained through maternal interview and review of medical records. Subjects will be followed through the delivery process to assess the course of pregnancy, labor, and to document any related maternal complications. Neonatal outcomes will be gathered from the medical record for up to 28 days of life or discharge, whichever occurs first.

Conditions

Preterm Birth

Keywords

proteomics; pregnancy; biomarkers; preterm birth

Outcome Measures

Primary Outcomes (1)

• Area under the receiver operator characteristic curve (AUROC) for prediction of preterm versus term birth using freshly collected specimens.

  Up to 30 months

Study Arms (2)

Women with preterm delivery

Women without preterm delivery

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women, 18 years or older, who are receiving prenatal care.

You may qualify if:

• Subject is 18 years of age or older
• 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

You may not qualify if:

• The subject has a planned cesarean section or induction of labor prior to 370/7 weeks of gestation
• 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.

Sponsors & Collaborators

• Sera Prognostics, Inc.: lead

Study Sites (18)

Maricopa Integrated Health Systems

Phoenix, Arizona, 85250, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

UC San Diego Health

San Diego, California, 92103, United States

Location

University of Colorado-Denver

Aurora, Colorado, 80045, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Oregon Health & Sciences University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29485, United States

Location

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

Regional Obstetrical Consultants

Chattanooga, Tennessee, 37405, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (16)

• 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.

  PMID: 26874297 BACKGROUND

• 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.

  PMID: 22682464 BACKGROUND

• 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.

  PMID: 9682045 BACKGROUND

• 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.

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• 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.

  PMID: 22579125 BACKGROUND

• 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.

  PMID: 15280344 BACKGROUND

• 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.

  PMID: 16335971 BACKGROUND

• 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.

  PMID: 17227133 BACKGROUND

• 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.

  PMID: 17203952 BACKGROUND

• 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.

  PMID: 17373840 BACKGROUND

• 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.

  PMID: 21074133 BACKGROUND

• 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.

  PMID: 25244460 BACKGROUND

• 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.

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• 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.

  PMID: 15663581 BACKGROUND

• 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.

  PMID: 33345877 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Durlin E Hickok, MD

  Sera Prognostics

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: June 1, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

US (18)