Clinical trial NCT06871917: Maternal Iron Deficiency and/or Iron Deficiency Anemia to Neonatal Hemoglobin Concentration and Iron Stores
Official title: The Relation of Maternal Iron Deficiency and/or Iron Deficiency Anemia to Neonatal Hemoglobin Concentration and Iron Stores
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Relation, Mother-Child
Keywords: anemia iron deficiency iron stores
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 370
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation the effect of maternal iron deficiency (ID) and/or iron deficiency anemia (IDA) to fetal haemoglobin concentration and fetal iron stores.
timeFrame: 2 years
Secondary outcomes:
measure: -Prevalence of maternal iron deficiency and/or iron deficiency anemia at birth in our community.
timeFrame: 2 years
measure: -Effect of maternal iron deficiency and/or iron deficiency anemia on early neonatal outcome .
timeFrame: 2 years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Naglaa Ali Ali
Study officials:
affiliation: prof of public health and community medicine, Faculty of medicine, Assuit university
name: Dalia G. Mahran, prof
role: STUDY_DIRECTOR
References:
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citation: Bernhardt GV, Jhancy M, Shivappa P, Bernhardt K, Pinto JRT. Relationship between maternal and cord blood iron status in women and their new born pairs. Vol. 14, Biomedical and Pharmacology Journal. 2021. p. 317-22.