Recruiting

Observational Study

Sponsor:

Medicines360

Code:

NCT07669935

Conditions

GDM

Preterm Preeclampsia

Preeclampsia

Fetal Growth Restriction (FGR)

Pregnancy Complications

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

None (this is an observational study with no intervention)

Study Details

Brief summary:

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.

Conditions

GDM

Preterm Preeclampsia

Preeclampsia

Fetal Growth Restriction (FGR)

Pregnancy Complications

Study ID

NCT07669935

Start date

Sep 8, 2026

Status verified date

Sep, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

5500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Retinal Imaging, Development of Algorithm

To develop a retinal imaging algorithm for risk prediction for preeclampsia.

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.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Carrie Fralick, MS

225-512-5546Carie.Fralick@womans.org

Locations

Woman's Hospital

Recruiting

Baton Rouge, Louisiana, United States, 70817

Contacts

Elizabeth Sutton

225-927-1300Elizabeth.Sutton@womans.org

Principal Investigator:

Elizabeth Sutton

More Information

Sponsor

Medicines360

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by Medicines360 on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.