Fetal Growth Restriction (FGR), GDM, Preeclampsia, Pregnancy Complications, Preterm Preeclampsia
Conditions
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.
Interventions
OTHERNone (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 \[i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)\].
Sponsors
Medicines360
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation. | 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. |
| To perform clinical validation of blood-based biomarkers using cut-offs at different timepoints in gestation. | 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. |
| To develop a retinal imaging algorithm for risk prediction for preeclampsia. | 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. |
| To validate the accuracy and test parameters of retinal imaging for risk prediction and management of pregnancies at risk for preeclampsia. | 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
| Measure | Time frame |
|---|---|
| To build a database including retinal imaging and pregnancy outcome data with linked biospecimen biobank. | From enrollment to approximately 4 weeks postpartum |
Outcome results
None listed