Preterm BirthTREETOPNCT02787213

A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor

An observational study of Preterm Birth, run by Sera Prognostics, Inc. at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 years, women only
Conditions the study is for: Preterm Birth
How many people: 5,011 participants
Where: 18 sitesUnited States
Study dates: Aug 2016to Jun 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Women only
No healthy volunteers
Adult

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

Who may be able to join

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

Who cannot join

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:

Show all 10Show fewer

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.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

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

Other trials in United States

About this study

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
Medical subject headings: Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02787213
Study group	Role	What they receive
Women with preterm delivery		Not described
Women without preterm delivery		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the receiver operator characteristic curve (AUROC) for prediction of preterm versus term birth using freshly collected specimens.
Measured: Up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Jun 2019

First posted1 Jun 2016 (estimated)
Study startAug 2016
Primary completionJun 2019
Study completionJun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Preterm BirthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 5,011 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02787213
Sponsor's protocol ID: SP 014
Acronym: TREETOP
Status last verified: Apr 2021
First submitted: 17 May 2016
Last updated: 14 Apr 2021
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes: Data will be shared once it is published.

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.
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.
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
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All Preterm Birth trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor
ClinicalTrials.gov ID: NCT02787213
Acronym / sponsor ID: TREETOP / SP 014
Conditions: Preterm Birth
Keywords: proteomics, pregnancy, biomarkers, preterm birth
Study type: Observational
Recruitment status: Completed
Enrolment: 5,011 participants (actual)
Lead sponsor: Sera Prognostics, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2016 (actual)
Primary completion: Jun 2019 (actual)
Study completion: Jun 2019 (actual)
First posted: 1 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Women with preterm delivery	–	–
Women without preterm delivery	–	–

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Pregnant women, 18 years or older, who are receiving prenatal care.

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
Background: PubMed 26874297Saade 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.
Background: PubMed 22682464Blencowe 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.
Background: PubMed 9682045Goldenberg 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.
Background: PubMed 974709Rush 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.
Background: PubMed 22579125Liu 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.
Background: PubMed 15280344Gravett 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.
Background: PubMed 16335971Ruetschi 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.
Background: PubMed 17227133Buhimschi 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.
Background: PubMed 17203952Gravett 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.
Background: PubMed 17373840Pereira 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.
Background: PubMed 21074133Esplin 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.
Background: PubMed 25244460Committee opinion no 611: method for estimating due date. Obstet Gynecol. 2014 Oct;124(4):863-866. doi: 10.1097/01.AOG.0000454932.15177.be.
Individual participant dataSharing planned: Yes. Data will be shared once it is published.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Durlin E Hickok, MD study chair

Sera Prognostics

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Preterm Birth, run by Sera Prognostics, Inc. at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02787213, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.