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

June 25, 2026 updated by: Medicines360

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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, 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)
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)].
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)
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)].
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)
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)].

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to approximately 4 weeks postpartum
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.
From enrollment to approximately 4 weeks postpartum
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.
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.
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.
From enrollment to approximately 4 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
To build a database including retinal imaging and pregnancy outcome data with linked biospecimen biobank.
Time Frame: From enrollment to approximately 4 weeks postpartum
From enrollment to approximately 4 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicines360

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 30, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 21, 2026

First Submitted That Met QC Criteria

June 21, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M360-A001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy Complications

Clinical Trials on None (this is an observational study with no intervention)

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