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

Sponsor
Medicines360
Study ID
NCT07669935
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • 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 \[i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)\].

Study Details

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.

Key Dates

First listed
Jun 25, 2026
Start date
Jul 30, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
5,500 participants (estimated)

Arms

  • Arm: Blood Based Biomarkers, Derivation Cohort
    To support the identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation, in blood-based biomarker products currently in development.
  • Arm: Blood Based Biomarkers, Validation Cohort
    To perform clinical validation of blood-based biomarkers using cut-offs at different timepoints in gestation, as defined above for identification of pregnancies at increased risk.
  • Arm: Retinal Imaging, Development of Algorithm
    To develop a retinal imaging algorithm for risk prediction for preeclampsia.
  • Arm: Retinal Imaging, Validation of Algorithm
    To validate the accuracy and test parameters of retinal imaging for risk prediction and management of pregnancies at risk for preeclampsia.

Primary Outcome Measure

Identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation. [ Time Frame: From enrollment to approximately 4 weeks postpartum ]

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