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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT05590260
Eligibility Criteria:
Inclusion Criteria:
* Established pregnancy \>20 weeks gestation by LMP and/or clinical assessment and/ Or USG
* Age: 15 years (or lower limit age eligible\*) to 49 years
* Confirmed moderate anemia (Hb 7.0 to 9.9 g/dL, 6-48 hour after delivery based on a venous blood sample on Hemocue®)
* Deliver in participating study hospital or health facility
* Able to provide informed consent
* Plans to remain in study area for duration of the study
Exclusion Criteria:
* IV Iron infusion received in past 3 weeks
* Contraindication to iron supplementation (some examples may include hemolytic anemia, allergy, severe infection)
* Blood transfusion already received or scheduled during the current hospital admission
* Known diagnosis of pre-existing depression or other psychiatric illness
* Stillbirth, major congenital anomaly, or neonatal loss prior to randomization
* Women testing positive and previously untreated for malaria
* Presenting with symptomatic anemia with dyspnea or fatigue and need for immediate correction
* Women with known hemoglobinopathy (sickle cell disease or thalassemia)
* Presence of severe allergic conditions such as severe asthma or known drug allergies
* Women presenting with any illness/condition requiring immediate medical care per physician's assessment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
49 Years
Study:
NCT05590260
Study Brief:
Protocol Section:
NCT05590260