Anemia Clinical Trial
— IDA & NIDAOfficial title:
Iron-deficiency and Non-iron-deficiency Anemia in Pregnancy and Infant Health in India
This is a sub-study nested into the existing NICHD Global Network for Women's & Children's Health Research Maternal Newborn Health (MNH) registry that is a prospective, observational population-based registry in Eastern Maharashtra, India. This study will assess the prevalence of iron deficiency anemia (IDA) and non-iron deficiency anemia (NIDA) in Eastern Maharashtra and will assess the association between both conditions and neo-natal and infant health outcomes (birth weight, gestational age at birth, weight-for-gestational-age z-score and infant hemoglobin concentration at 6 weeks). The investigators will also assess the relative strength of the association between anemia in the 1st trimester and 3rd trimester (after iron needs have increased but mothers may have been taking iron folic acid (IFA) supplements for several months) and infant health outcomes.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - A pregnant women in the first trimester of pregnancy - Enrolled in the Maternal & Newborn Health Registry - At least 18 years of age - Residing in the area of a selected Primary Health Center with the intention to remain in the area through child birth and 6-weeks post-partum Exclusion Criteria: - Having multiple fetuses |
Country | Name | City | State |
---|---|---|---|
India | Lata Medical Research Foundation | Nagpur | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Boston University Charles River Campus | Lata Medical Research Foundation |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Birthweight | 0-48 hours | ||
Secondary | gestational age at birth | <48 hours | ||
Secondary | weight-for-gestational-age z-score | <48 hours | ||
Secondary | infant hemoglobin at 6 weeks | 6 weeks |
Status | Clinical Trial | Phase | |
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