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

NCT07669935 | Not Yet Recruiting

• 1 other identifier: M360-A001
• Study Type: observational
• Target: 5,500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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.

  From enrollment to approximately 4 weeks postpartum

• To perform clinical validation of blood-based biomarkers using cut-offs 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.

  From enrollment to approximately 4 weeks postpartum

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

  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.

  From enrollment to approximately 4 weeks postpartum

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

  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.

  From enrollment to approximately 4 weeks postpartum

Secondary Outcomes (1)

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

  From enrollment to approximately 4 weeks postpartum

Study Arms (4)

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.

Other: None (this is an observational study with no intervention)

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.

Other: None (this is an observational study with no intervention)

Retinal Imaging, Development of Algorithm

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

Other: None (this is an observational study with no intervention)

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.

Other: None (this is an observational study with no intervention)

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

Blood Based Biomarkers, Derivation Cohort; Blood Based Biomarkers, Validation Cohort; Retinal Imaging, Development of Algorithm; Retinal Imaging, Validation of Algorithm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Nulliparous women of child-bearing age \>=18 years with singleton pregnancies exhibiting diverse demographics with racial and ethnic backgrounds representative of the general US and UK populations.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medicines360: lead

Biospecimen

Retention: SAMPLES WITH DNA

Study procedures will include the collection of clinical data, blood samples, and ocular imaging.

MeSH Terms

Conditions

Pre-Eclampsia; Fetal Growth Retardation; Pregnancy Complications

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 25, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06