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

N/ANot Yet RecruitingNCT07669935

Medicines3605,500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

5,500

Conditions

GDM Preterm Preeclampsia Preeclampsia Fetal Growth Restriction (FGR)Pregnancy Complications

Interventions

This is an observational study evaluating biomarkers from blood and ocular imaging for prediction of pregnancy complications and associated risks \[i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)\].

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

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.

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.