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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT03851120
Eligibility Criteria:
Inclusion Criteria:
Each pregnant woman must meet all of the following criteria to be enrolled in this study:
1\. Indonesian pregnant women in the 2nd trimester of gestational period 2. healthy pregnancy (as measured by hemoglobin level, pregnancy status, pregnancy history) 3. Having a normal blood pressure 4. Planning to stay in the study area until the child is 6 months old 5. Willing to sign informed consent 5. Having a legally acceptable representative who is capable to understand the informed consent document and providing consent on the subject's behalf
Exclusion Criteria:
Each pregnant women meeting any of the following criteria will be excluded from the study:
1. Having foreign objects in the body due to trauma, artificial heart value, metal objects or ferromagnetic (plate, screw, clip, prosthetic), and electronic device (pacemaker, cochlear implant, insulin pump), and being claustrophobic
2. Having history of previous gestational diabetes or been diagnosed to have gestational diabetes
3. Having history of type 1 and type 2 diabetes
4. Severe anemia
Inclusion Criteria for Follow-up at 24 months:
1. Child age above 24 months from the BRAVE intervention project
2. Having a legally acceptable representative who is capable to understand the informed consent document and providing consent on the subject's behalf
Exclusion Criteria for Follow-up at 24 months:
1\. Child being hospitalized during the study/data collection
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT03851120
Study Brief:
Protocol Section:
NCT03851120