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Completed

NCT Number: NCT04708665

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

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Key information

Conditions

Anemia Anemia of Pregnancy Anemia, Hypochromic Anemia, Iron Deficiency Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Lata Medical Research Foundation

Nagpur, Maharashtra, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Birthweight

    Time frame: 0-48 hours

Secondary outcomes

  1. gestational age at birth

    Time frame: <48 hours

  2. weight-for-gestational-age z-score

    Time frame: <48 hours

  3. infant hemoglobin at 6 weeks

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • Lata Medical Research Foundation

Registry information

Official study title

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

Acronym: IDA & NIDA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2021
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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