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

Anemia Clinical Trial

— IDA & NIDA  

Official title:

Iron-deficiency and Non-iron-deficiency Anemia in Pregnancy and Infant Health in India

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04708665
• Other study ID #: 55207436
• Status: Recruiting
• Start date: November 23, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: January 2021
• Source: Boston University Charles River Campus
• Contact: Lindsey M Locks, ScD MPH
• Phone: 617-353-2710
• Email: LMLocks[@]bu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anemia
• Anemia of Pregnancy
• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency

Locations

Country	Name	City	State
India	Lata Medical Research Foundation	Nagpur	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Boston University Charles River Campus	Lata Medical Research Foundation

Country where clinical trial is conducted

India, 

Outcome

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