Not a traditional drug phase: None (this is an observational study with no intervention) for GDM
ASPIRE will be a multi-site, prospective, two-part longitudinal, noninterventional watch-and-measure (no experimental treatment required) 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.
Official registry: https://clinicaltrials.gov/study/NCT07669935 · Medicines360 · enrollment listed as 5,500
What this phase means
This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.
They plan to enroll about 5,500 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
A Multi-Site, Prospective, Two-Part Longitudinal, Observational Cohort Study Of Pregnant Women To Evaluate Biomarkers For Prediction Of Pregnancy Complications
Interventions: None (this is an observational study with no intervention)
Primary outcome (registry wording): Identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation.
Who it is for (from inclusion criteria)
- Ages 18 Years to 99 Years
- Women only
- 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
Who the registry excludes
- Inability to provide blood
- 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 treatment clinical study
Public study contact (from the registry)
Carrie Fralick, MS
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
5 listed- Yale New Haven Health System — Bridgeport, Connecticut (recruiting)
- Yale New Haven Health System — New Haven, Connecticut (recruiting)
- Woman's Hospital — Baton Rouge, Louisiana (recruiting)
- St. Lawrence Health — Potsdam, New York (active_not_recruiting)
- UTHealth Houston — Houston, Texas (recruiting)
FAQ about this NCT record
Is NCT07669935 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07669935?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07669935?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary