ASPIRE: Predicting Pregnancy Complications Using Blood and Eye Imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ASPIRE is a multi-site, prospective, two-part observational study of nulliparous singleton pregnancies to identify biomarkers from blood and ocular imaging that may predict PE, FGR, and GDM. The study will follow participants over time without any intervention. Eligibility focuses on adults 18 and older with a single viable fetus between 10 0/7 and 17 6/7 weeks gestation who can consent and comply with follow-up. Key exclusions include multiple gestations, inability to provide blood, known fetal anomalies, and anticipated inability to complete delivery data at the study site. The research is sponsored by Medicines360 with sites at Yale New Haven Health System and Woman’s Hospital in Louisiana.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale New Haven Health System
  Bridgeport, Connecticut, United States Recruiting
• Yale New Haven Health System
  New Haven, Connecticut, United States Recruiting
• Woman's Hospital
  Baton Rouge, Louisiana, United States Recruiting
• UTHealth Houston
  Houston, Texas, United States Recruiting
• St. Lawrence Health
  Potsdam, New York, United States Active not recruiting

Study contacts

• Study coordinator: Carrie Fralick, MS
• Email: Carie.Fralick@womans.org
• Phone: 225-512-5546

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.