Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-99
SponsorMedicines360
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
None (this is an observational study with no intervention)
Other interventionThis is an observational study evaluating biomarkers from blood and ocular imaging for prediction of pregnancy complications and associated risks \[i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)\].
Treatment groups
5,500 Participants
are divided into 4 treatment groupsGroup A: Blood Based Biomarkers, Derivation Cohort1 intervention
Group B: Blood Based Biomarkers, Validation Cohort1 intervention
Group C: Retinal Imaging, Development of Algorithm1 intervention
Group D: Retinal Imaging, Validation of Algorithm1 intervention
Trial outcomes
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.
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.
Time frame
From enrollment to approximately 4 weeks postpartum2
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.
Time frame
From enrollment to approximately 4 weeks postpartum3
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.
Time frame
From enrollment to approximately 4 weeks postpartum4
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.
Time frame
From enrollment to approximately 4 weeks postpartumSecondary 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 postpartumSponsors and contacts
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Source ClinicalTrials.gov