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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

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

Contact the study team

Official record on ClinicalTrials.gov — NCT07669935

Locations in the U.S.

LouisianaWoman's Hospital, Baton Rouge

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.