An observational study in Stillbirth, sponsored by RTI International. Not yet recruiting at 5 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by RTI International · Observational
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:
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.
121 studies on the registry are indexed under Stillbirth; 34 are open to participants now.
This study's planned enrollment of 7,000 is above the median of 480 across 55 observational studies indexed under Stillbirth.
Browse Stillbirth studies →RTI International is the lead sponsor of 84 studies on the registry; 18 are open to participants now.
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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.
Early Pregnancy Cohort Inclusion Criteria
Late Pregnancy Cohort
Exclusion Criteria:
* 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
* 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
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
Time frame: 7 days post delivery
Stillbirth
Stillbirth among all births
Time frame: 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
Time frame: Delivery
Neonatal mortality
Early neonatal mortality among live births
Time frame: 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
Time frame: Delivery
Cause of stillbirth
Classification of cause of stillbirth using published classification system
Time frame: Delivery
Apgar score
Among fetal growth restriction (\<10th%ile) infants, 5-minute Apgar score
Time frame: Delivery
Neurologic injury
Evidence of neurologic injury among infants with severe FGR
Time frame: Birth to 7 days
Hypoxic-ischemic encephalopathy (HIE)
HIE based on the Sarnat examination among infants with severe fetal growth restriction.
Time frame: Birth to 7 days
Intraventricular hemorrhage
Diagnosis of intraventricular hemorrhage among infants with severe fetal growth restricition.
Time frame: delivery
Hypotension
Hypotension requiring vasopressor or inotrope for cardiovascular support among infants with severe fetal growth restriction
Time frame: 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
Time frame: Birth to 7 days
Seizures
Neonatal seizures among infants with severe fetal growth restriction
Time frame: Birth to 7 days
Gestational age at delivery
Estimated gestational age at delivery based on early ultrasound among infants with severe fetal growth restriction.
Time frame: Delivery
Days admitted to the Neonatal Intensive Care Unit (NICU)
Number days admitted to the NICU among infants with severe fetal growth restriction
Time frame: Birth to day 28
Neonatal mortality
Neonaal death (\<=28 days) among infants with severe fetal growth restriction.
Time frame: Birth to 28 days post-delivery
Plan to share: No
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