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Not yet recruiting NCT07669935

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

— Observational GDM Preterm Preeclampsia Preeclampsia Fetal Growth Restriction (FGR)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: None (this is an observational study with no intervention).
Who it may be relevant to
Registry conditions: GDM, Preterm Preeclampsia, Preeclampsia, Fetal Growth Restriction (FGR). Basic parameters: 18 years — 99 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • 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]
  • 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]
  • To develop a retinal imaging algorithm for risk prediction for preeclampsia. [Time frame: 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]
Secondary outcome measures (1)
  • To build a database including retinal imaging and pregnancy outcome data with linked biospecimen biobank. [Time frame: From enrollment to approximately 4 weeks postpartum]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07669935 · M360-A001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗