Maternal Iron Deficiency and/or Iron Deficiency Anemia to Neonatal Hemoglobin Concentration and Iron Stores

May 20, 2025 updated by: Naglaa A. Ali, Assiut University

The Relation of Maternal Iron Deficiency and/or Iron Deficiency Anemia to Neonatal Hemoglobin Concentration and Iron Stores

study the relationship between maternal iron deficiency (ID) and/or iron deficiency anemia (IDA) to neonatal hemoglobin concentration and iron stores at birth

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Iron deficiency is a common micronutrient deficiency in pregnant women specially in developing countries as increasing demands on maternal iron stores as consequences of expansion of maternal red blood cell mass and the requirement of the developing fetus.

The relationship between maternal iron stores and fetal iron extraction has received considerable attention as iron deficiency places neonates at high risks for cognitive, motor, social-emotional, and neurodevelopmental problem. moreover, requirement of iron is high for rapid growth and differentiation of the fetus and thus a well-balanced iron hemostasis is required. This balance can be threatened in neonates born to iron compromised mothers.

Some studies have suggested that the fetus reflects maternal iron stores, but this concept is still being debated as few other studies show contrasting results, majority of studies have been done in developed countries. To draw the consensus regarding the result, more studies needed to clarify the effect of maternal iron status on fetal stores are required. Proper understanding of the relationship between maternal and neonatal iron indices will help in formulating protocols that is required to improve the maternal and neonatal outcomes, so investigating the effect maternal iron on fetal iron indices can be of great value, so that early intervention to prevent or reverse the adverse effect of iron deficiency on development issues much before iron deficiency becomes sever can be instituted.

Study Type

Observational

Enrollment (Estimated)

370

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

Study Locations

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study will include all pregnant women meet the inclusion criteria and their infant pairs at the time of delivery.

Description

Inclusion Criteria:

  • All pregnant women and their infant pairs who have given consent to participate.
  • Mothers Age: 21-40 years' old.
  • Term infants (37-42 weeks of gestation) with birth weight ≥2500 g born to mothers who had an uncomplicated normal singleton vaginal delivery or caesarian section delivery was included.

Exclusion Criteria:

  • Mothers with a history of antepartum hemorrhage, pre-mature labor pain, high-risk pregnancy (eg. history of trauma and severe infection during pregnancy), severe hyperemesis, pre-eclampsia severe anemia requiring blood transfusion, and any chronic medical illnesses as: gestational diabetes, hypertension, hypothyroidism, epilepsy, liver disease, renal disease cardiorespiratory disease, immunodeficiency syndrome, and hematological (other causes of anemia)
  • infants who suspected with congenital and/or chromosomal anomalies and pathological jaundice, also multiple pregnancy was excluded from the study.
  • Mothers withdrew from given a written consent will be excluded from the study.

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
Measure Description
Time Frame
Evaluation the effect of maternal iron deficiency (ID) and/or iron deficiency anemia (IDA) to fetal haemoglobin concentration and fetal iron stores.
Time Frame: 2 years
evaluation the correlation between ID and IDA in maternal and neonatal samples
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
-Prevalence of maternal iron deficiency and/or iron deficiency anemia at birth in our community.
Time Frame: 2 years
finding the prevalence of ID and/or IDA in pregnant mother
2 years
-Effect of maternal iron deficiency and/or iron deficiency anemia on early neonatal outcome .
Time Frame: 2 years
exploring early neonatal outcomes after delivery
2 years

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Dalia G. Mahran, prof, prof of public health and community medicine, Faculty of medicine, Assuit university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

June 8, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 12, 2025

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAMAssiutU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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