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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

ASPIRE studies whether signs in blood and eye images can help predict pregnancy problems and poor outcomes. These problems include preeclampsia (high blood pressure during pregnancy), poor growth of the baby, and diabetes during pregnancy. It is for adults pregnant with one baby who have had no previous births at 20 weeks or later; it observes pregnancy without testing a treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You have had no previous births at 20 weeks of pregnancy or later.
  • An ultrasound shows one living baby and a pregnancy between 10 weeks, 0 days and 17 weeks, 6 days.
  • You can agree to join and complete study steps and follow-up visits.

Who can't join

  • You are pregnant with more than one baby.
  • You cannot give a blood sample.
  • Your baby has a known chromosome problem (a problem with genetic material) or a birth defect that may affect health, survival, body function, or thinking.
  • You cannot, or likely cannot, complete follow-up through birth at the study site, such as because of a move or change in pregnancy care.
  • You are in a study that tests a treatment or other intervention, or were in one within the past two months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

LA

NY