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

• None (this is an observational study with no intervention) (Other): This is an observational study evaluating biomarkers from blood and ocular imaging for prediction of pregnancy complications and associated risks \[i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)\].

Primary outcomes

• Identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation. [From enrollment to approximately 4 weeks postpartum]: Validation of the performance of predefined blood-based biomarkers (and/or algorithms) for prediction of PE, FGR, and GDM. Performance will be evaluated against standardized clinical phenotypes.
• To perform clinical validation of blood-based biomarkers using cut-offs at different timepoints in gestation. [From enrollment to approximately 4 weeks postpartum]: Validation of the performance of predefined blood-based biomarkers (and/or algorithms) for prediction of PE, FGR, and GDM. Performance will be evaluated against standardized clinical phenotypes.
• To develop a retinal imaging algorithm for risk prediction for preeclampsia. [From enrollment to approximately 4 weeks postpartum]: Validation of the accuracy of retinal imaging and associated algorithms for risk stratification of pre-eclampsia; specifically, performance will be evaluated in predicting preterm PE, early-onset PE, term PE, and PE with severe features.
• To validate the accuracy and test parameters of retinal imaging for risk prediction and management of pregnancies at risk for preeclampsia. [From enrollment to approximately 4 weeks postpartum]: Validation of the accuracy of retinal imaging and associated algorithms for risk stratification of pre-eclampsia; specifically, performance will be evaluated in predicting preterm PE, early-onset PE, term PE, and PE with severe features.

Secondary outcomes

• To build a database including retinal imaging and pregnancy outcome data with linked biospecimen biobank. [From enrollment to approximately 4 weeks postpartum]

Sex: Female, ages: 18 Years to 99 Years, accepts healthy volunteers

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.