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

RecruitingObservational studyHealthy volunteers welcome

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

Who can join

Ages 18 to 99 · Women · Healthy volunteers welcome

Full eligibility criteria

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.

About the study

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.

What is being tested

None (this is an observational study with no intervention) (other)

Sponsor: Medicines360 · Participants: 5,500 · Started: Sep 8, 2026

Contact the study team

Carrie Fralick, MS · Phone: 225-512-5546

Official record on ClinicalTrials.gov — NCT07669935

Locations in the U.S.

Connecticut	Yale New Haven Health System, Bridgeport Yale New Haven Health System, New Haven
Louisiana	Woman's Hospital, Baton Rouge
Texas	UTHealth Houston, Houston

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.