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

A Multi-Site, Prospective, Two-Part Longitudinal, Observational Cohort Study Of Pregnant Women To Evaluate Biomarkers For Prediction Of Pregnancy Complications

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.

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.