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

25 juni 2026 bijgewerkt door: Medicines360

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

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

5500

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: 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)].
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.
Ander: 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)].
Retinal Imaging, Development of Algorithm
To develop a retinal imaging algorithm for risk prediction for preeclampsia.
Ander: 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)].
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.
Ander: 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)].

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
To build a database including retinal imaging and pregnancy outcome data with linked biospecimen biobank.
Tijdsspanne: From enrollment to approximately 4 weeks postpartum
From enrollment to approximately 4 weeks postpartum

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Medicines360

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 juli 2026

Primaire voltooiing (Geschat)

1 juli 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

21 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 juni 2026

Eerst geplaatst (Werkelijk)

25 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • M360-A001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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