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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Retinal Imaging, Development of Algorithm | To develop a retinal imaging algorithm for risk prediction for preeclampsia. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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)]. |
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To build a database including retinal imaging and pregnancy outcome data with linked biospecimen biobank. | From enrollment to approximately 4 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D005317 | Fetal Growth Retardation |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005315 | Fetal Diseases |
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Study procedures will include the collection of clinical data, blood samples, and ocular imaging.
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |