RecruitingNCT07669935ClinicalTrials.gov record

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

GDM · Preterm Preeclampsia · Preeclampsia · Fetal Growth Restriction (FGR) · Pregnancy Complications

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Observational
Phase: Not applicable / not listed
Age range: 18 years - 99 years
Sex eligible: Female
Healthy volunteers: Accepted
Participants: 5500 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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 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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not reported
Masking: Not reported

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)

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)

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)

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)

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

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation.