Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07470320
Eligibility Criteria:
Inclusion Criteria:
* Female, aged 18 years or above
* Willing and able to give informed consent for participation in the study
* Able to read and understand written and spoken English to comprehend study materials and give informed consent
* Non-pregnant women in good general health OR pregnant women who fall into one of the following:
* Healthy pregnancy
* Pre-eclampsia (PET) - defined by clinical diagnostic criteria, including hypertension and proteinuria
* Gestational diabetes mellitus (GDM) - diagnosed by standard glucose tolerance tests during pregnancy
* Fetal growth restriction (FGR) - diagnosed based on fetal weight or Doppler abnormalities
* Predisposed to PET - high-risk factors for PET such as maternal type 1 or type 2 diabetes, autoimmune diseases or multiple pregnancies
Exclusion Criteria:
* Non-pregnant participants with active health conditions that could confound study outcomes
* Pregnant participants with conditions unrelated to PET, GDM or FGR that could influence EV profiles e.g. active infections or malignancies
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07470320
Study Brief:
Protocol Section:
NCT07470320