NICHD Stillbirth Research Consortium: Research on Advanced Diagnostics and Management of All Pregnancies to Prevent Stillbirth (ROADMAPS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 7,000
- 试验地点
- 5
- 主要终点
- 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.
研究概览
简要总结
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)
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Early Pregnancy Cohort Inclusion Criteria
- •18 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
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 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
次要结局
- 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)
- Apgar score(Delivery)
- Neurologic injury(Birth to 7 days)
- Hypoxic-ischemic encephalopathy (HIE)(Birth to 7 days)
- Intraventricular hemorrhage(delivery)
- Hypotension(Birth to 7 days)
- Cord arterial blood gas(Birth to 7 days)
- Seizures(Birth to 7 days)
- Gestational age at delivery(Delivery)
- Days admitted to the Neonatal Intensive Care Unit (NICU)(Birth to day 28)
- Neonatal mortality(Birth to 28 days post-delivery)
研究者
Elizabeth McClure
Senior Research Epidemiologist
RTI International