Health TrialsbyHealthPanel

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

ConditionStillbirth
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRTI International

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

7,000 Participants
are grouped into 2 trial groups
Group A: Early Pregnancy Cohort
Group B: Late Pregnancy Cohort

Trial outcomes

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

Time frame
7 days post delivery

Secondary outcomes

1

Stillbirth

Stillbirth among all births

Time frame
Delivery
2

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
3

Neonatal mortality

Early neonatal mortality among live births

Time frame
Up to 7 days after delivery
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RTI International

Lead sponsor

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

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: