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 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT04868669
Eligibility Criteria:
Pregnant women permanently residing in the icddr,b service area of Matlab fulfilling the following criteria:
Inclusion Criteria:
* aged 18-39 years
* in the first trimester of pregnancy (before 14 weeks of gestation)
* BMI 16-24.99 kg/m\^2 measured on enrollment
* willing to participate in the study
Exclusion criteria
* multiple pregnancy (carrying two or more fetuses)
* threatened abortion, persistent pervaginal bleeding, or cervical incompetence
* history of three or more consecutive abortions
* history of gestational diabetes, macrosomia, gestational hypertension, preeclampsia/eclampsia in a prior pregnancy
* chronic diseases, such as hypertension, heart disease, chronic obstructive pulmonary disease, chronic kidney disease, chronic liver disease, pancreatic diseases, Crohn's disease, ulcerative colitis, diabetes mellitus, thyroid dysfunction, immunological diseases, malignancy or any other diseases which could impede compliance with the study protocol
* taking medications known to influence fetal growth, such as insulin, thyroid hormones, glucocorticoids
* known case of serious psychiatric or behavioral disorders, such as schizophrenia, bipolar disorder
* scored as moderate or worse on enrollment on any one of the subscales of the Depression, Anxiety and Stress Scales-21 (DASS-21)
* inability to read or write Bengali
* belonging to moderately or severely food insecure households as measured by the Household Food Insecurity Access Scale (HFIAS)
* having a plan to move or deliver outside the study area
* women practicing some form of vegetarianism
* women belonging to a household from which another woman is already enrolled in the study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT04868669
Study Brief:
Protocol Section:
NCT04868669