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NCT Number: NCT07669935

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

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Key information

Conditions

GDM Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Restriction (FGR) Fetal Growth Retardation Growth Disorders Hypertension, Pregnancy-Induced Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Preeclampsia Pregnancy Complications Preterm Preeclampsia Urogenital Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)].

Primary outcomes

  1. 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

    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.

  2. To perform clinical validation of blood-based biomarkers using cut-offs at different timepoints in gestation.

    Time frame: From enrollment to approximately 4 weeks postpartum

    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.

  3. To develop a retinal imaging algorithm for risk prediction for preeclampsia.

    Time frame: From enrollment to approximately 4 weeks postpartum

    Validation of the accuracy of retinal imaging and associated algorithms for risk stratification of pre-eclampsia; specifically, performance will be evaluated in predicting preterm PE, early-onset PE, term PE, and PE with severe features.

  4. To validate the accuracy and test parameters of retinal imaging for risk prediction and management of pregnancies at risk for preeclampsia.

    Time frame: From enrollment to approximately 4 weeks postpartum

    Validation of the accuracy of retinal imaging and associated algorithms for risk stratification of pre-eclampsia; specifically, performance will be evaluated in predicting preterm PE, early-onset PE, term PE, and PE with severe features.

Secondary outcomes

  1. To build a database including retinal imaging and pregnancy outcome data with linked biospecimen biobank.

    Time frame: From enrollment to approximately 4 weeks postpartum

Sponsors and collaborators

Lead sponsor

Medicines360

Other

Registry information

Official study title

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

Acronym: ASPIRE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 25, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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