Iron Deficiency Anemia and Non-iron Deficiency Anemia in Pregnancy in India

NCT04708665 | Completed

• 1 other identifier: 55207436
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia; Anemia, Iron Deficiency; Anemia of Pregnancy

Keywords

Anemia of Pregnancy

Outcome Measures

Primary Outcomes (1)

• Birthweight

  0-48 hours

Secondary Outcomes (3)

• gestational age at birth

  <48 hours

• weight-for-gestational-age z-score

  <48 hours

• infant hemoglobin at 6 weeks

  6 weeks

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 pregnant women and their infants in Eastern Maharashtra, India. Mothers will be enrolled in the first trimester of pregnancy and mothers and infants will be followed up until 6 weeks post-partum.

You may qualify if:

• 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

You may not qualify if:

• Having multiple fetuses

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Lata Medical Research Foundation: collaborator

Study Sites (1)

Lata Medical Research Foundation

Nagpur, Maharashtra, India

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood will be drawn from pregnant women to assess iron status, hemoglobin, and inflammation. Hemoglobin will be assessed with a heel prick in infants and a finger prick in women.

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lindsey M Locks, ScD MPH

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 14, 2021
• Study Start: November 23, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)