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NCT07669935RecruitingAccepts Healthy Volunteers

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

Medicines360

Start Date

9/8/2026

Completion Date

12/1/2028

Summary

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.

Eligibility Criteria

Age Range: 18 years to 99 years

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.

Interventions

OTHER

None (this is an observational study with no intervention)

Interested in This Trial?

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Conditions

GDMPreterm PreeclampsiaPreeclampsiaFetal Growth Restriction (FGR)Pregnancy Complications

Locations

Woman's Hospital

Baton Rouge, Louisiana 70817

United States

St. Lawrence Health

Potsdam, New York 13676

United States