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NCT07669935
Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study
Conditions: GDM, Preterm Preeclampsia, Preeclampsia, Fetal Growth Restriction (FGR), Pregnancy Complications
Sex: Female
Ages: 18 Years – 99 Years
Healthy volunteers: Yes
Enrollment: 5500
Sponsor: Medicines360
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
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.
Source: ClinicalTrials.gov (NCT07669935). StuddyBuddy aggregates publicly available trial information.