Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study
GDM · Preterm Preeclampsia · Preeclampsia · Fetal Growth Restriction (FGR) · Pregnancy Complications
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - 99 años
- Sexo admitido
- Femenino
- Voluntarios sanos
- Aceptados
- Participantes
- 5500 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Población del estudio
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.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
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 \[i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)\].
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation.
Plazo: 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.
Plazo: 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.
Plazo: 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.
Plazo: 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.
Medidas secundarias
To build a database including retinal imaging and pregnancy outcome data with linked biospecimen biobank.
Plazo: From enrollment to approximately 4 weeks postpartum
No informado en este registro.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (5)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
5 centros
Yale New Haven Health SystemBridgeport, Connecticut, United StatesReclutando
Yale New Haven Health SystemNew Haven, Connecticut, United StatesReclutando
Woman's HospitalBaton Rouge, Louisiana, United StatesReclutando
St. Lawrence HealthPotsdam, New York, United StatesActivo, sin reclutamiento
UTHealth HoustonHouston, Texas, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- Medicines360
- Inicio del estudio
- 8 sept 2026 Real
- Finalización primaria
- 1 jul 2028 Estimado
- Finalización del estudio
- 1 dic 2028 Estimado
- Primera publicación
- 25 jun 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Multi-Site, Prospective, Two-Part Longitudinal, Observational Cohort Study Of Pregnant Women To Evaluate Biomarkers For Prediction Of Pregnancy Complications
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026