StillbirthROADMAPSNCT07745101
Research On Advanced Diagnostics and Management of All Pregnancies to Prevent Stillbirth (ROADMAPS)
An observational study of Stillbirth, run by RTI International at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stillbirth
- How many people
- 7,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Aug 2026to 31 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
The Collaborative Action for Research to End Stillbirth (CARES) Research Center at Columbia University
New York, New York, 10027
Uma Reddy, MD, MPH, 240-401-3605, uma.reddy@yale.edu
Uma Reddy, MD, MPH
Old Dominion University
Norfolk, Virginia, 23529
George Saade, MD, 757-446-5257, saadegr@odu.edu
Oregon Health & Science University
Portland, Oregon, 97239
Karen Gibbins, MD, MSCI, 503-494-2101, gibbins@ohsu.edu
Karen Gibbins, MD, MSCI
University of Utah
Salt Lake City, Utah, 84112
Robert Silver, MD, 801-581-8425, bob.silver@hsc.utah.edu
Robert Silver, MD
University of California Center for Stillbirth Prevention
San Diego, California, 92093
Mana Parast, MD, PhD, 858-534-8631, mparast@health.ucsd.edu
Mana Parast, MD, PhD
About this study
Official title: NICHD Stillbirth Research Consortium: Research on Advanced Diagnostics and Management of All Pregnancies to Prevent Stillbirth (ROADMAPS)
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)
Read the detailed description
In the United States, stillbirth defined as fetal death at or beyond 20 weeks' gestation affects approximately 5.48/1,000 births, or 1 in 180 pregnancies, a rate that surpasses many other high-resource countries, highlighting major opportunities for improvement and prevention. Prevention of stillbirth in the United States requires improved risk stratification to identify pregnancies at highest risk. Unfortunately, commonly used pre-pregnancy risk factors such as parity, advanced maternal age, and body mass index are poor predictors of stillbirth and explain only a small proportion of stillbirth risk. Critical gaps in stillbirth risk stratification hamper efforts to accurately identify at-risk pregnancies early enough to enable effective interventions and ultimately reduce stillbirth and those on the path to stillbirth.
FGR is frequently a manifestation of underlying placental dysfunction and one of the strongest known risk factors for stillbirth, with a stillbirth rate of 1.5% (two-fold increased risk). FGR, defined as a fetus that fails to reach its growth potential, is difficult to diagnose. The term small for gestational age, defined as estimated or actual birthweight below the 10th percentile, is often used interchangeably with FGR, although it does not distinguish between constitutionally small fetuses and those affected by pathologic growth restriction.
Early onset FGR is well recognized as a major risk factor for stillbirth, yet nearly half of FGR fetuses are not detected antenatally. The development of abnormal fetal umbilical artery (UA) Doppler indices differentiates between constitutionally small fetuses and those with increased risk of stillbirth. Estimated fetal weight below the 3rd percentile has been associated with a further increased risk of adverse perinatal outcome irrespective of Doppler indices (3-fold risk over 3rd to 5th percentile, and 4- to 7-fold risk over 5th to 10th percentile).
To address the need for more timely identification of pregnancies at risk for stillbirth or FGR, we will conduct a longitudinal prospective cohort study to develop a prediction model to identify pregnancies at <14 weeks gestation with increased risk of stillbirth or severe FGR. We will use the Hadlock nomogram to define birthweight percentile since we seek to identify at-risk pregnancies prenatally.
Placental Dysfunction
Placental dysfunction is a central biological pathway underlying both FGR and many stillbirths. It reflects the inability of the placenta to meet the metabolic demands of a growing fetus. However, placental dysfunction is heterogenous and difficult to diagnose during an ongoing pregnancy. Post delivery, placental dysfunction can be identified following a complete pathologic evaluation, using standardized pathologic criteria, including maternal vascular malperfusion (MVM), fetal vascular malperfusion (FVM), inflammatory villitis of unknown etiology (VUE) or acute chorioamnionitis (ACA) patterns of injury, or as Massive Perivillous Fibrin Deposition/Maternal Floor Infarction (MPVFD/MFI) as defined by the Amsterdam Workshop Guidelines.
Despite advances in placental pathology, there are currently no validated biomarkers that can reliably identify placental dysfunction during pregnancy. The placenta generates and utilizes considerable energy to support its own function consuming half of the oxygen and nutrients supplied to the pregnant uterus. Measurement of trophoblast energetics in vitro post-delivery allows assessment into placental "health" and ability to support the fetus.
To address the need for more timely identification of pregnancies at risk for stillbirth and FGR, we will utilize innovative placental imaging and biomarkers to examine early indicators of placental dysfunction before 14 weeks' gestation and their association with stillbirth and severe FGR (Secondary Objective).
Perinatal Nutrition
Perinatal nutrition is a potentially modifiable factor that influences placental function and pregnancy outcomes. Higher diet quality has been associated with lower allostatic load, while suboptimal perinatal nutrition is associated with stillbirth and adverse pregnancy outcomes. Nutritional status is critical for the health of the pregnant individual, placental function, and developing offspring. By understanding the role of nutrition in pregnancy outcomes, we will be able to better identify high-risk individuals and potential interventions.
Decreased Fetal Movements
DFM are generally assessed as part of standard care; however, assessment and management vary widely, and evidence regarding their predictive value is inconsistent. Within this cohort, we will collect standardized data on fetal movements and evaluate their association with adverse outcomes. These data will be used to develop a risk stratification framework and inform best practices for the clinical management of DFM.
Together, achieving these objectives will provide a better understanding of these factors will provide robust information to inform clinical practice to improve birth outcomes in the United States.
- Conditions
- Stillbirth
- Keywords
- Stillbirth, Fetal growth restriction
- Medical subject headings
- Stillbirth, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days post delivery
Secondary outcomes (15)
Stillbirth
Stillbirth among all births
Measured: Delivery
Fetal growth restriction (FGR)
Fetal growth restriction <10%ile 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
Measured: Delivery
Neonatal mortality
Early neonatal mortality among live births
Measured: Up to 7 days after delivery
Placental dysfunction among stillbirths, fetal growth restriction and neonatal deaths
Placental dysfunction will be defined using the Amsterdam Criteria including the following characteristics: Maternal vascular malperfusion (MVM), fetal vascular malperfusion (FVM), VUE, or MPVFD/MFI; other important findings associated with placental insufficiency; and/or cord abnormalities associated with placental insufficiency
Measured: Delivery
Cause of stillbirth
Classification of cause of stillbirth using published classification system
Measured: Delivery
Apgar score
Among fetal growth restriction (<10th%ile) infants, 5-minute Apgar score
Measured: Delivery
Neurologic injury
Evidence of neurologic injury among infants with severe FGR
Measured: Birth to 7 days
Hypoxic-ischemic encephalopathy (HIE)
HIE based on the Sarnat examination among infants with severe fetal growth restriction.
Measured: Birth to 7 days
Intraventricular hemorrhage
Diagnosis of intraventricular hemorrhage among infants with severe fetal growth restricition.
Measured: delivery
Hypotension
Hypotension requiring vasopressor or inotrope for cardiovascular support among infants with severe fetal growth restriction
Measured: Birth to 7 days
Cord arterial blood gas
Cord arterial blood gas demonstrating pH <7.0 or base excess > 12 mEq/L among infants with severe fetal growth restriction
Measured: Birth to 7 days
Seizures
Neonatal seizures among infants with severe fetal growth restriction
Measured: Birth to 7 days
Gestational age at delivery
Estimated gestational age at delivery based on early ultrasound among infants with severe fetal growth restriction.
Measured: Delivery
Days admitted to the Neonatal Intensive Care Unit (NICU)
Number days admitted to the NICU among infants with severe fetal growth restriction
Measured: Birth to day 28
Neonatal mortality
Neonaal death (<=28 days) among infants with severe fetal growth restriction.
Measured: Birth to 28 days post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for StillbirthStudies 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
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Old Dominion University, University of Utah, Columbia University, University of California, San Diego, Oregon Health and Science University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Elizabeth McClure, RTI International
- Investigators
- Elizabeth McClure, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745101
- Sponsor's protocol ID
- SBRC ROADMAPS
- Other IDs
- UM2HD119552
- Acronym
- ROADMAPS
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zimet, G. D., Dahlem, N. W., Zimet, S. G. & Farley, G. K. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52, 30-41.
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.
PubMed 35533873Steyerberg 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.
PubMed 25981519Silver 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.
PubMed 38789073Riley 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.
PubMed 32188600Society 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.
PubMed 32407785Marshall 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.
PubMed 34968458Khong 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.
PubMed 27223167Kawakita 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.
PubMed 41022129Jack-Roberts C, Maples P, Kalkan B, Edwards K, Gilboa E, Djuraev I, Zou S, Hoepner L, Fordjour L, Lee WC, Kral J, Dalloul M, Jiang X. Gestational diabetes status and dietary intake modify maternal and cord blood allostatic load markers. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e001468. doi: 10.1136/bmjdrc-2020-001468.
PubMed 33093129International 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.
PubMed 28285990Howell 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.
PubMed 41572249Ego A, Monier I, Skaare K, Zeitlin J. Antenatal detection of fetal growth restriction and risk of stillbirth: population-based case-control study. Ultrasound Obstet Gynecol. 2020 May;55(5):613-620. doi: 10.1002/uog.20414.
PubMed 31364201Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
PubMed 3651732Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NICHD Stillbirth Research Consortium: Research on Advanced Diagnostics and Management of All Pregnancies to Prevent Stillbirth (ROADMAPS)
- ClinicalTrials.gov ID
- NCT07745101
- Acronym / sponsor ID
- ROADMAPS / SBRC ROADMAPS
- Conditions
- Stillbirth
- Keywords
- Stillbirth, Fetal growth restriction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Old Dominion University, University of Utah, Columbia University, University of California, San Diego, Oregon Health and Science University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 4 Aug 2026 (actual)
- 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.
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)
Detailed description
In the United States, stillbirth defined as fetal death at or beyond 20 weeks' gestation affects approximately 5.48/1,000 births, or 1 in 180 pregnancies, a rate that surpasses many other high-resource countries, highlighting major opportunities for improvement and prevention. Prevention of stillbirth in the United States requires improved risk stratification to identify pregnancies at highest risk. Unfortunately, commonly used pre-pregnancy risk factors such as parity, advanced maternal age, and body mass index are poor predictors of stillbirth and explain only a small proportion of stillbirth risk. Critical gaps in stillbirth risk stratification hamper efforts to accurately identify at-risk pregnancies early enough to enable effective interventions and ultimately reduce stillbirth and those on the path to stillbirth.
FGR is frequently a manifestation of underlying placental dysfunction and one of the strongest known risk factors for stillbirth, with a stillbirth rate of 1.5% (two-fold increased risk). FGR, defined as a fetus that fails to reach its growth potential, is difficult to diagnose. The term small for gestational age, defined as estimated or actual birthweight below the 10th percentile, is often used interchangeably with FGR, although it does not distinguish between constitutionally small fetuses and those affected by pathologic growth restriction.
Early onset FGR is well recognized as a major risk factor for stillbirth, yet nearly half of FGR fetuses are not detected antenatally. The development of abnormal fetal umbilical artery (UA) Doppler indices differentiates between constitutionally small fetuses and those with increased risk of stillbirth. Estimated fetal weight below the 3rd percentile has been associated with a further increased risk of adverse perinatal outcome irrespective of Doppler indices (3-fold risk over 3rd to 5th percentile, and 4- to 7-fold risk over 5th to 10th percentile).
To address the need for more timely identification of pregnancies at risk for stillbirth or FGR, we will conduct a longitudinal prospective cohort study to develop a prediction model to identify pregnancies at <14 weeks gestation with increased risk of stillbirth or severe FGR. We will use the Hadlock nomogram to define birthweight percentile since we seek to identify at-risk pregnancies prenatally.
Placental Dysfunction
Placental dysfunction is a central biological pathway underlying both FGR and many stillbirths. It reflects the inability of the placenta to meet the metabolic demands of a growing fetus. However, placental dysfunction is heterogenous and difficult to diagnose during an ongoing pregnancy. Post delivery, placental dysfunction can be identified following a complete pathologic evaluation, using standardized pathologic criteria, including maternal vascular malperfusion (MVM), fetal vascular malperfusion (FVM), inflammatory villitis of unknown etiology (VUE) or acute chorioamnionitis (ACA) patterns of injury, or as Massive Perivillous Fibrin Deposition/Maternal Floor Infarction (MPVFD/MFI) as defined by the Amsterdam Workshop Guidelines.
Despite advances in placental pathology, there are currently no validated biomarkers that can reliably identify placental dysfunction during pregnancy. The placenta generates and utilizes considerable energy to support its own function consuming half of the oxygen and nutrients supplied to the pregnant uterus. Measurement of trophoblast energetics in vitro post-delivery allows assessment into placental "health" and ability to support the fetus.
To address the need for more timely identification of pregnancies at risk for stillbirth and FGR, we will utilize innovative placental imaging and biomarkers to examine early indicators of placental dysfunction before 14 weeks' gestation and their association with stillbirth and severe FGR (Secondary Objective).
Perinatal Nutrition
Perinatal nutrition is a potentially modifiable factor that influences placental function and pregnancy outcomes. Higher diet quality has been associated with lower allostatic load, while suboptimal perinatal nutrition is associated with stillbirth and adverse pregnancy outcomes. Nutritional status is critical for the health of the pregnant individual, placental function, and developing offspring. By understanding the role of nutrition in pregnancy outcomes, we will be able to better identify high-risk individuals and potential interventions.
Decreased Fetal Movements
DFM are generally assessed as part of standard care; however, assessment and management vary widely, and evidence regarding their predictive value is inconsistent. Within this cohort, we will collect standardized data on fetal movements and evaluate their association with adverse outcomes. These data will be used to develop a risk stratification framework and inform best practices for the clinical management of DFM.
Together, achieving these objectives will provide a better understanding of these factors will provide robust information to inform clinical practice to improve birth outcomes in the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
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
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.
Time frame: 7 days post delivery
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
15 secondary outcomes
Stillbirth
Time frame: Delivery
Fetal growth restriction (FGR)
Time frame: Delivery
Neonatal mortality
Time frame: Up to 7 days after delivery
Placental dysfunction among stillbirths, fetal growth restriction and neonatal deaths
Time frame: Delivery
Cause of stillbirth
Time frame: Delivery
Apgar score
Time frame: Delivery
Neurologic injury
Time frame: Birth to 7 days
Hypoxic-ischemic encephalopathy (HIE)
Time frame: Birth to 7 days
Intraventricular hemorrhage
Time frame: delivery
Hypotension
Time frame: Birth to 7 days
Cord arterial blood gas
Time frame: Birth to 7 days
Seizures
Time frame: Birth to 7 days
Gestational age at delivery
Time frame: Delivery
Days admitted to the Neonatal Intensive Care Unit (NICU)
Time frame: Birth to day 28
Neonatal mortality
Time frame: Birth to 28 days post-delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- BackgroundZimet, G. D., Dahlem, N. W., Zimet, S. G. & Farley, G. K. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52, 30-41.
- Background: PubMed 35533873Zhou 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.
- Background: PubMed 25981519Steyerberg 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.
- Background: PubMed 38789073Silver 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.
- Background: PubMed 32188600Riley 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.
- Background: PubMed 32407785Society 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.
- Background: PubMed 34968458Marshall 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.
- Background: PubMed 27223167Khong 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.
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- Stillbirth Research Consortium project websiteLink provided by the sponsor.
- Environmental Justice IndexLink provided by the sponsor.
- The Pittsburgh Sleep Quality Index (PSQI)Link provided by the sponsor.
- Working to address the tragedy of stillbirthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Elizabeth McClure, PhD principal investigator
RTI International
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stillbirth, run by RTI International at 5 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 0 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth McClure, PhD (919-316-3773, mcclure@rti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 7 days post delivery). 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 NCT07745101, which also lists 20 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 4 Aug 2026.