Research On Advanced Diagnostics and Management of All Pregnancies to Prevent Stillbirth (ROADMAPS)

NCT07745101 | Not Yet Recruiting DMC

• 2 other identifiers: SBRC ROADMAPSUM2HD119552
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 5

Brief Summary

The primary objective of the Stillbirth Research Consortium (SBRC) longitudinal cohort study is to develop and evaluate a robust multivariable prediction model to identify pregnancies at \<14 weeks gestation that are at increased risk of stillbirth or fetal growth restriction (FGR), often reflecting underlying placental dysfunction. Secondary objectives include:

• To evaluate placental pathology among cases and selected controls using standardized Amsterdam criteria.
• To identify key aspects of perinatal nutrition contributing to placental dysfunction
• To determine relationships between maternal biomarkers, placental pathology and energetics, with the goal of identifying biomarkers predictive of placental dysfunction
• To develop a risk stratification model for pregnancies complicated by decreased fetal movements (DFM)

Conditions

Stillbirth

Keywords

Stillbirth; Fetal growth restriction

Outcome Measures

Primary Outcomes (1)

• The primary outcome is a composite outcome of stillbirth or severe placental dysfunction, defined as the occurrence of birth at or beyond 20.0 weeks of gestation.

  Stillbirth, Fetal Growth Restriction (FGR) or Neonatal Mortality \<7 days among births at ≥20.0 weeks' gestation meeting one or more of the following: * Stillbirth among births at \>20.0 weeks' gestation * FGR defined as: FGR \< 3rd percentile FGR 3 - \<10th percentile with at least one of the following criteria: Umbilical artery Doppler \> 95th percentile for either systolic/diastolic ratio (S/D), pulsatility index (PI), or resistance index (RI) Oligohydramnios Non-reassuring fetal heart rate or biophysical profile \- Neonatal death less than or equal to 7 days, excluding non-medical causes Primary outcome Time Frame: Birth through 7-days post delivery

  7 days post delivery

Secondary Outcomes (15)

• Stillbirth

  Delivery

• Fetal growth restriction (FGR)

  Delivery

• Neonatal mortality

  Up to 7 days after delivery

• Placental dysfunction among stillbirths, fetal growth restriction and neonatal deaths

  Delivery

• Cause of stillbirth

  Delivery

Study Arms (2)

Early Pregnancy Cohort

* 18 years or older * Gestational age at enrollment: Between 12.0 and 13.6 weeks of gestation * Pregnant individuals receiving care at participating clinical sites with intent of delivering at study hospital * Consent to participate in study procedures through 6 weeks postpartum

Late Pregnancy Cohort

* 18 years or older * Gestational age at enrollment: greater than or equal to 28.0 weeks gestational age * Clinical indications of risk (FGR \<10th percentile or report of decreased fetal movement) * Pregnant individual receiving care at participating clinical sites with intent of delivering at study hospital * Consent to participate in study procedures through 6 weeks postpartum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population for the primary objective will include pregnant individuals who are screened and enrolled between 12.0 and 13.6 weeks of gestation at participating clinical sites ("Early Pregnancy Cohort"). Individuals may also be screened and enrolled at later gestational ages greater than or equal to 28 weeks gestation to address the secondary objectives of the project, including DFM, and FGR and relationship to perinatal nutrition and allostatic load ("Late Pregnancy Cohort"). This study will collect discarded neonatal cord blood post-delivery and will request access to neonatal medical record charts using appropriate HIPAA Authorization. We will also collect paternal saliva samples, when possible, after obtaining consent from the father.

You may qualify if:

• years of age
• Gestational age at enrollment: Between 12.0 and 13.6 weeks of gestation
• Pregnant individuals receiving care at participating clinical sites with intent of delivering at study hospital
• Consent to participate in study procedures through 6 weeks postpartum
• Late Pregnancy Cohort
• years or older
• Gestational age at enrollment: greater than or equal to 28.0 weeks gestational age
• Clinical indications of risk FGR \<10th percentile or report of decreased fetal movement)
• Pregnant individual receiving care at participating clinical sites with intent of delivering at study hospital
• Consent to participate in study procedures through 6 weeks postpartum

You may not qualify if:

• Evidence of fetal genetic anomaly or major structural malformation
• Known fetal aneuploidy based on chorionic villus sampling
• Positive cell-free fetal DNA screening for aneuploidy
• Multifetal gestation
• Less than 18 years of age
• Not fluent in either English or Spanish

Sponsors & Collaborators

• RTI International: lead
• Old Dominion University: collaborator
• University of Utah: collaborator
• Columbia University: collaborator
• University of California, San Diego: collaborator
• Oregon Health and Science University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (5)

University of California Center for Stillbirth Prevention

San Diego, California, 92093, United States

Location

The Collaborative Action for Research to End Stillbirth (CARES) Research Center at Columbia University

New York, New York, 10027, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Old Dominion University

Norfolk, Virginia, 23529, United States

Location

Related Publications (20)

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  BACKGROUND

• Zhou MS, Hasson RE, Baylin A, Leung CW. Associations between Diet Quality and Allostatic Load in US Adults: Findings from the National Health and Nutrition Examination Survey, 2015-2018. J Acad Nutr Diet. 2022 Dec;122(12):2207-2217. doi: 10.1016/j.jand.2022.05.001. Epub 2022 May 6.

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• Steyerberg EW, Harrell FE Jr. Prediction models need appropriate internal, internal-external, and external validation. J Clin Epidemiol. 2016 Jan;69:245-7. doi: 10.1016/j.jclinepi.2015.04.005. Epub 2015 Apr 18. No abstract available.

  PMID: 25981519 BACKGROUND

• Silver RM, Reddy U. Stillbirth: we can do better. Am J Obstet Gynecol. 2024 Aug;231(2):152-165. doi: 10.1016/j.ajog.2024.05.042. Epub 2024 May 23.

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• Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract available.

  PMID: 32188600 BACKGROUND

• Society for Maternal-Fetal Medicine (SMFM). Electronic address: pubs@smfm.org; Martins JG, Biggio JR, Abuhamad A. Society for Maternal-Fetal Medicine Consult Series #52: Diagnosis and management of fetal growth restriction: (Replaces Clinical Guideline Number 3, April 2012). Am J Obstet Gynecol. 2020 Oct;223(4):B2-B17. doi: 10.1016/j.ajog.2020.05.010. Epub 2020 May 12.

  PMID: 32407785 BACKGROUND

• Marshall NE, Abrams B, Barbour LA, Catalano P, Christian P, Friedman JE, Hay WW Jr, Hernandez TL, Krebs NF, Oken E, Purnell JQ, Roberts JM, Soltani H, Wallace J, Thornburg KL. The importance of nutrition in pregnancy and lactation: lifelong consequences. Am J Obstet Gynecol. 2022 May;226(5):607-632. doi: 10.1016/j.ajog.2021.12.035. Epub 2021 Dec 27.

  PMID: 34968458 BACKGROUND

• Khong TY, Mooney EE, Ariel I, Balmus NC, Boyd TK, Brundler MA, Derricott H, Evans MJ, Faye-Petersen OM, Gillan JE, Heazell AE, Heller DS, Jacques SM, Keating S, Kelehan P, Maes A, McKay EM, Morgan TK, Nikkels PG, Parks WT, Redline RW, Scheimberg I, Schoots MH, Sebire NJ, Timmer A, Turowski G, van der Voorn JP, van Lijnschoten I, Gordijn SJ. Sampling and Definitions of Placental Lesions: Amsterdam Placental Workshop Group Consensus Statement. Arch Pathol Lab Med. 2016 Jul;140(7):698-713. doi: 10.5858/arpa.2015-0225-CC. Epub 2016 May 25.

  PMID: 27223167 BACKGROUND

• Kawakita T, Diab YH, Onishi K, Saade G. Nutrition Pattern and Adverse Pregnancy Outcomes in Nulliparous Individuals: A Cluster Analysis. Am J Perinatol. 2026 May;43(7):955-962. doi: 10.1055/a-2712-5518. Epub 2025 Sep 29.

  PMID: 41022129 BACKGROUND

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  PMID: 33093129 BACKGROUND

• International Stillbirth Alliance Collaborative for Improving Classification of Perinatal Deaths; Flenady V, Wojcieszek AM, Ellwood D, Leisher SH, Erwich JJHM, Draper ES, McClure EM, Reinebrant HE, Oats J, McCowan L, Kent AL, Gardener G, Gordon A, Tudehope D, Siassakos D, Storey C, Zuccollo J, Dahlstrom JE, Gold KJ, Gordijn S, Pettersson K, Masson V, Pattinson R, Gardosi J, Khong TY, Froen JF, Silver RM. Classification of causes and associated conditions for stillbirths and neonatal deaths. Semin Fetal Neonatal Med. 2017 Jun;22(3):176-185. doi: 10.1016/j.siny.2017.02.009. Epub 2017 Mar 9.

  PMID: 28285990 BACKGROUND

• Howell A, Thilaganathan B, Margelyte R, Burden C, Cheng V, Sandall J, Viner M, Brigante L, Anumba D, Winter C, Harlev-Lam B, Draycott T, Judge A, Lenguerrand E; Tommy's National Centre for Maternity Improvement. Why current risk factor-based approaches fall short in predicting stillbirth: a national cohort study of nulliparous women in England. BMC Med. 2026 Jan 22;24(1):94. doi: 10.1186/s12916-025-04598-7.

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  PMID: 31364201 BACKGROUND

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  PMID: 17906047 BACKGROUND

• Caradeux J, Martinez-Portilla RJ, Basuki TR, Kiserud T, Figueras F. Risk of fetal death in growth-restricted fetuses with umbilical and/or ductus venosus absent or reversed end-diastolic velocities before 34 weeks of gestation: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Feb;218(2S):S774-S782.e21. doi: 10.1016/j.ajog.2017.11.566. Epub 2017 Dec 9.

  PMID: 29233550 BACKGROUND

• Billioux, A., Verlander, K., Anthony, S., & Alley, D. (2017). Standardized screening for health-related social needs in clinical settings: The Accountable Health Communities Screening Tool. National Academy of Medicine Perspectives, 1-9.

  BACKGROUND

• Azpurua H, Funai EF, Coraluzzi LM, Doherty LF, Sasson IE, Kliman M, Kliman HJ. Determination of placental weight using two-dimensional sonography and volumetric mathematic modeling. Am J Perinatol. 2010 Feb;27(2):151-5. doi: 10.1055/s-0029-1234034. Epub 2009 Aug 3.

  PMID: 19653142 BACKGROUND

• Arleo EK, Troiano RN, da Silva R, Greenbaum D, Kliman HJ. Utilizing two-dimensional ultrasound to develop normative curves for estimated placental volume. Am J Perinatol. 2014 Sep;31(8):683-8. doi: 10.1055/s-0033-1357265. Epub 2013 Oct 9.

  PMID: 24108663 BACKGROUND

Related Links

• Stillbirth Research Consortium project website
• Environmental Justice Index
• PROMIS Anxiety Scoring Manual
• The Pittsburgh Sleep Quality Index (PSQI)
• Working to address the tragedy of stillbirth

Biospecimen

Retention: SAMPLES WITH DNA

Blood, plasma, serum, saliva, PAXGene DNA, umbilical cord segment, placental tissue

MeSH Terms

Conditions

Stillbirth; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders

Study Officials

• Elizabeth McClure, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth McClure, PhD

CONTACT

919-316-3773; mcclure@rti.org

Carla Bann, PhD

CONTACT

919-485-2773; cmb@rti.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Epidemiologist

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)