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:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT07031557
Eligibility Criteria:
Inclusion Criteria:
* Signature informed consent
* Willingness to participate in the study and ability to complete the study-related questionnaires
* Women in the first trimester of pregnancy at the time of inclusion in the study
* Age between 18 and 45 years at the time of recruitment in the study
* Absence of secondary osteoporosis (induced by diseases or medication use)
* Absence of current or past conditions that could potentially interfere with bone metabolism (e.g., thyroid, kidney, or liver diseases)
* Women of normal weight or with class I obesity (BMI between 18,5 and 34)
Exclusion Criteria:
* Absence of informed consent
* Low compliance and/or inability to complete the study-related questionnaires
* Women not beyond the first trimester of pregnancy and pregnancy-related or pre-existing comorbidities
* Age under 18 or over 45 years
* BMI less than 18.5 or greater than 34
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07031557
Study Brief:
Protocol Section:
NCT07031557