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Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study

Recruitingn/aAges 18 Years - 99 YearsFemaleMedicines360
NCT07669935 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

ASPIRE will be a multi-site, prospective, two-part longitudinal, noninterventional observational cohort study of nulliparous singleton pregnant women to evaluate biomarkers from blood and ocular imaging for prediction of pregnancy complications \[i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)\] and risk of adverse outcomes.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years * Nulliparous (no previous births ≥20wk GA) * Single viable fetus at the dating ultrasound scan with an ultrasound estimated gestational age of 10 0/7-17 6/7 weeks of gestation * Ability to consent and comply with study procedures and follow-up Exclusion Criteria: * Multiple gestation * Inability to provide blood * Known fetal chromosomal abnormalities or structural Anomaly (a structural or functional defect with the following three characteristics: 1) of prenatal origin; 2) present at the time of live birth or fetal demise, or in utero; 3) affecting (or has the propensity to affect) the health, survival, or physical or cognitive functioning of the individual * Known or anticipated inability to complete study follow-up through delivery at the study site (e.g., planned relocation, transfer of obstetric care to a non-participating institution, or other circumstances making delivery outcome data unavailable) * Current or recent (within two months) participation in an interventional clinical study.
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What it tests

  • None (this is an observational study with no intervention)
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Where

2 sites
Woman's Hospital
Baton Rouge, United States
St. Lawrence Health
Potsdam, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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