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 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT03973359
Eligibility Criteria:
Inclusion Criteria:
* Adult (≥ 18 years old) pregnant women at ≤13 weeks gestation
* Presence of HCMV IgG and absence of IgM or presence of high avidity IgG with or without IgM
* Presence of HCMV-specific IgG and absence of IgM or presence of high avidity IgG in case of positive IgM at ≤13 weeks gestation documented by medical report or by retrospective antibody determination on samples stored at ≤13 weeks (for women enrolled at delivery)
* Willingness to participate in the study
* Ability to understand information material
* Written informed consent
Exclusion Criteria:
* Unreliable women as judged by the investigator
* Women not willing to give written consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03973359
Study Brief:
Protocol Section:
NCT03973359