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 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT04798833
Eligibility Criteria:
Inclusion Criteria:
* Resides in a village with LHW coverage in participating union councils (clusters) in Astore, Diamer, Shigar, Ghanche, Kharmang, and Skardu, districts of GB, Pakistan
* In their 3rd trimester of pregnancy (≥ week 27 gestational age)
* Intends to be present in the study catchment area between day 29 and 35 postnatal age
* Provides written informed consent or assent
* Starting in approximately month 26 of the study, only women ≥36 weeks of gestational age will be enrolled.
Exclusion Criteria:
* Does not reside within the study's catchment area at the time of enrolment
* Plans to relocate outside of the study catchment area within one month after the delivery of their newborn(s) and not return to the study catchment area
* Does not provide written informed consent or assent
* Lives in a village without LHW coverage
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT04798833
Study Brief:
Protocol Section:
NCT04798833