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CompletedNCT02787213TREETOPUpdated Apr 14, 2021

A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor

An observational study in Preterm Birth, sponsored by Sera Prognostics, Inc.. Completed at 18 sites in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-04-14.

Sponsored by Sera Prognostics, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,011
Ages
18 Years to 55 Years
Sex
Female
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Study 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.

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Conditions studied

  • Preterm Birth

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Keywords

  • proteomics
  • pregnancy
  • biomarkers
  • preterm birth
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In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 5,011 is above the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Sera Prognostics, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,011 participants (actual)
Patient registry
No

Groups and cohorts

  • Women with preterm delivery
  • Women without preterm delivery
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What researchers measure

Primary outcomes

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

    Time frame: Up to 30 months

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Study locations

18 sites
  • Maricopa Integrated Health Systems
    Phoenix, Arizona 85250, United States
  • University of California, Irvine Medical Center
    Orange, California 92868, United States
  • UC San Diego Health
    San Diego, California 92103, United States
  • University of Colorado-Denver
    Aurora, Colorado 80045, United States
  • Denver Health Medical Center
    Denver, Colorado 80204, United States
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
  • Indiana University Medical Center
    Indianapolis, Indiana 46202, United States
  • Ochsner Baptist Medical Center
    New Orleans, Louisiana 70115, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • Baystate Medical Center
    Springfield, Massachusetts 01199, United States
  • University of North Carolina
    Chapel Hill, North Carolina 27599, United States
  • Duke University Medical Center
    Durham, North Carolina 27705, United States
  • Oregon Health & Sciences University
    Portland, Oregon 97239, United States
  • Thomas Jefferson University Hospital
    Philadelphia, Pennsylvania 19107, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29485, United States
  • Greenville Health System
    Greenville, South Carolina 29605, United States
  • Regional Obstetrical Consultants
    Chattanooga, Tennessee 37405, United States
  • University of Texas Medical Branch
    Galveston, Texas 77555, United States
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References and documents

Publications

  • 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. PubMed 26874297 ↗
  • 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. PubMed 22682464 ↗
  • 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. PubMed 9682045 ↗
  • 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. PubMed 974709 ↗
  • 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. Erratum In: Lancet. 2012 Oct 13;380(9850):1308. PubMed 22579125 ↗
  • 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. Erratum In: JAMA. 2004 Nov;292(19):2340. PubMed 15280344 ↗
  • 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. PubMed 16335971 ↗
  • 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. PubMed 17227133 ↗
  • 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. PubMed 17203952 ↗
  • 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. PubMed 17373840 ↗
  • 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. PubMed 21074133 ↗
  • 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. PubMed 25244460 ↗
  • 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. PubMed 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. PubMed 9249923 ↗
  • 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. PubMed 15663581 ↗
  • 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. PubMed 33345877 ↗

Individual participant data

Plan to share: Yes — Data will be shared once it is published.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02787213
Lead sponsor
Sera Prognostics, Inc.
Responsible party
Sponsor
First posted
Jun 1, 2016
Start date
Aug 2016
Primary completion
Jun 2019
Completion
Jun 2019
Last update
Apr 14, 2021

Study contacts

Durlin E Hickok, MD
study chair · Sera Prognostics

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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