Iron Deficiency Anemia and Non-iron Deficiency Anemia in Pregnancy in India (IDA & NIDA)

January 12, 2021 updated by: Lindsey Locks, Boston University Charles River Campus

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lindsey M Locks, ScD MPH
  • Phone Number: 617-353-2710
  • Email: LMLocks@bu.edu

Study Contact Backup

  • Name: Patricia Hibberd, MD PhD
  • Phone Number: 617-358-2046
  • Email: plh0@bu.edu

Study Locations

  • India
    • Maharashtra
      • Nagpur, Maharashtra, India
        • Recruiting
        • Lata Medical Research Foundation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Birthweight
Time Frame: 0-48 hours
0-48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
gestational age at birth
Time Frame: <48 hours
<48 hours
weight-for-gestational-age z-score
Time Frame: <48 hours
<48 hours
infant hemoglobin at 6 weeks
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University Charles River Campus

Collaborators

Lata Medical Research Foundation

Investigators

  • Principal Investigator: Lindsey M Locks, ScD MPH, Boston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2020

Primary Completion (Anticipated)

January 31, 2022

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55207436

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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