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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation. [Срок оценки: From enrollment to approximately 4 weeks postpartum]
• To perform clinical validation of blood-based biomarkers using cut-offs at different timepoints in gestation. [Срок оценки: From enrollment to approximately 4 weeks postpartum]
• To develop a retinal imaging algorithm for risk prediction for preeclampsia. [Срок оценки: 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. [Срок оценки: From enrollment to approximately 4 weeks postpartum]

Вторичные конечные точки (1)

• To build a database including retinal imaging and pregnancy outcome data with linked biospecimen biobank. [Срок оценки: From enrollment to approximately 4 weeks postpartum]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07669935 · M360-A001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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