A new model aims to predict stillbirth before it happens
NCT ID NCT07745101
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This study is developing a prediction model to identify pregnancies at increased risk of stillbirth or fetal growth restriction, often caused by placental problems. Researchers will follow 7,000 pregnant individuals, collecting data from early pregnancy through delivery and postpartum. The goal is to use clinical information, biomarkers, and placental examinations to create a risk score that could guide care and potentially prevent stillbirth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- No drug or device; this is an observational study developing a risk prediction model using clinical data, biomarkers, and placental pathology.
- What this could lead to
- If successful, this could lead to a tool that identifies high-risk pregnancies early, allowing closer monitoring and interventions to prevent stillbirth.
- What could go wrong
- The prediction model may not be accurate enough for widespread use, and the study's findings might not apply to all populations. It is observational, so it cannot prove that any intervention reduces stillbirth.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 7,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 Exclusion Criteria: * 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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Old Dominion University
Norfolk, Virginia, 23529, United States
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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The Collaborative Action for Research to End Stillbirth (CARES) Research Center at Columbia University
New York, New York, 10027, United States
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University of California Center for Stillbirth Prevention
San Diego, California, 92093, United States
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University of Utah
Salt Lake City, Utah, 84112, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Placental clues from a past pregnancy may guide treatment to prevent future complications
- Can your phone hear your baby kick? new app aims to monitor fetal movements
- Drug may ease emotional pain after pregnancy loss procedure
- Grief support for parents after baby loss put to the test
- New fetal heart monitor could unlock secrets of stillbirth