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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04708665
Other study ID # 55207436
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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