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:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT05856318
Eligibility Criteria:
Pregnancy Arm Inclusion Criteria:
To be included in the trial the participant must:
* Nulliparous (no previous pregnancy beyond 20 weeks' gestation)
* Actively considering pregnancy within approximately 12 months
* Aged between 18 and 45 years
* Ability to consent and willing to participate
Pregnancy Arm Exclusion Criteria:
The presence of any of the following will preclude participant inclusion:
* Currently pregnant
* Established infertility
* Planning or actively using fertility treatments (e.g. IVF, ICSI, FET, IUI)
* Assigned male sex at birth
* Autoimmune disease (e.g. rheumatoid arthritis, lupus)
* Thrombophilia
* Type 1 diabetes
* Known advanced chronic kidney disease (stages 4-5)
* Malignant hypertension
* Clinically manifest CVD (e.g. previous myocardial infarction, stroke)
* Active cancer/being treated for cancer currently (other than skin cancer)
* Any other condition preventing full participation in the study
Non-Pregnancy Arm Inclusion criteria
To be included in the trial the participant must:
* Nulliparous (no previous pregnancy beyond 20 weeks' gestation)
* Not planning to conceive during next 18 months
* Aged between 18 and 45 years
* Ability to consent and willing to participate
Non-Pregnancy Exclusion Criteria
The presence of any of the following will preclude participant inclusion:
* Currently pregnant
* Planning or actively using fertility treatments (e.g. IVF, ICSI, FET, IUI)
* Assigned male sex at birth
* Autoimmune disease (e.g. rheumatoid arthritis, lupus)
* Thrombophilia
* Type 1 diabetes
* Known advanced chronic kidney disease (stages 4-5)
* Malignant hypertension
* Clinically manifest CVD (e.g. previous myocardial infarction, stroke)
* Active cancer/being treated for cancer currently (other than skin cancer)
* Any other condition preventing full participation in the study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05856318
Study Brief:
Protocol Section:
NCT05856318