Relation, Mother-ChildNCT06871917
Maternal Iron Deficiency and/or Iron Deficiency Anemia to Neonatal Hemoglobin Concentration and Iron Stores
An observational study of Relation, Mother-Child, run by Assiut University at 1 site in Egypt.
Trial summary
study the relationship between maternal iron deficiency (ID) and/or iron deficiency anemia (IDA) to neonatal hemoglobin concentration and iron stores at birth Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Relation, Mother-Child
- How many people
- 370 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jun 2025to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will include all pregnant women meet the inclusion criteria and their infant pairs at the time of delivery.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Naglaa Ali Ali
Asyut
naglaa A ali, master, 01014616671, naglaaali11995@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Relation, Mother-Child
- Keywords
- anemia iron deficiency iron stores
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the effect of maternal iron deficiency (ID) and/or iron deficiency anemia (IDA) to fetal haemoglobin concentration and fetal iron stores.
evaluation the correlation between ID and IDA in maternal and neonatal samples
Measured: 2 years
Secondary outcomes (2)
-Prevalence of maternal iron deficiency and/or iron deficiency anemia at birth in our community.
finding the prevalence of ID and/or IDA in pregnant mother
Measured: 2 years
-Effect of maternal iron deficiency and/or iron deficiency anemia on early neonatal outcome .
exploring early neonatal outcomes after delivery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start8 Jun 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Relation, Mother-ChildStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa A. Ali, Assiut University
- Investigators
- Dalia G. Mahran, prof, Study director, prof of public health and community medicine, Faculty of medicine, Assuit university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871917
- Sponsor's protocol ID
- FAMAssiutU
- Status last verified
- May 2025
- First submitted
- 7 Mar 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Krafft A, Huch R, Breymann C. Impact of parturition on iron status in nonanaemic iron deficiency. Eur J Clin Invest. 2003 Oct;33(10):919-23. doi: 10.1046/j.1365-2362.2003.01244.x.
PubMed 14511365Bentley DP. Iron metabolism and anaemia in pregnancy. Clin Haematol. 1985 Oct;14(3):613-28.
PubMed 3907911Mei Z, Cogswell ME, Looker AC, Pfeiffer CM, Cusick SE, Lacher DA, Grummer-Strawn LM. Assessment of iron status in US pregnant women from the National Health and Nutrition Examination Survey (NHANES), 1999-2006. Am J Clin Nutr. 2011 Jun;93(6):1312-20. doi: 10.3945/ajcn.110.007195. Epub 2011 Mar 23.
PubMed 21430118Scholl TO. Iron status during pregnancy: setting the stage for mother and infant. Am J Clin Nutr. 2005 May;81(5):1218S-1222S. doi: 10.1093/ajcn/81.5.1218.
PubMed 15883455Lozoff B. Iron deficiency and child development. Food Nutr Bull. 2007 Dec;28(4 Suppl):S560-71. doi: 10.1177/15648265070284S409.
PubMed 18297894Delaney KM, Guillet R, Fleming RE, Ru Y, Pressman EK, Vermeylen F, Nemeth E, O'Brien KO. Umbilical Cord Serum Ferritin Concentration is Inversely Associated with Umbilical Cord Hemoglobin in Neonates Born to Adolescents Carrying Singletons and Women Carrying Multiples. J Nutr. 2019 Mar 1;149(3):406-415. doi: 10.1093/jn/nxy286.
PubMed 30770543Bernhardt 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation of Maternal Iron Deficiency and/or Iron Deficiency Anemia to Neonatal Hemoglobin Concentration and Iron Stores
- ClinicalTrials.gov ID
- NCT06871917
- Acronym / sponsor ID
- FAMAssiutU
- Conditions
- Relation, Mother-Child
- Keywords
- anemia iron deficiency iron stores
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 8 Jun 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include all pregnant women meet the inclusion criteria and their infant pairs at the time of delivery.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
-Prevalence of maternal iron deficiency and/or iron deficiency anemia at birth in our community.
Time frame: 2 years
-Effect of maternal iron deficiency and/or iron deficiency anemia on early neonatal outcome .
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 14511365Krafft A, Huch R, Breymann C. Impact of parturition on iron status in nonanaemic iron deficiency. Eur J Clin Invest. 2003 Oct;33(10):919-23. doi: 10.1046/j.1365-2362.2003.01244.x.
- Background: PubMed 3907911Bentley DP. Iron metabolism and anaemia in pregnancy. Clin Haematol. 1985 Oct;14(3):613-28.
- Background: PubMed 21430118Mei Z, Cogswell ME, Looker AC, Pfeiffer CM, Cusick SE, Lacher DA, Grummer-Strawn LM. Assessment of iron status in US pregnant women from the National Health and Nutrition Examination Survey (NHANES), 1999-2006. Am J Clin Nutr. 2011 Jun;93(6):1312-20. doi: 10.3945/ajcn.110.007195. Epub 2011 Mar 23.
- Background: PubMed 15883455Scholl TO. Iron status during pregnancy: setting the stage for mother and infant. Am J Clin Nutr. 2005 May;81(5):1218S-1222S. doi: 10.1093/ajcn/81.5.1218.
- Background: PubMed 18297894Lozoff B. Iron deficiency and child development. Food Nutr Bull. 2007 Dec;28(4 Suppl):S560-71. doi: 10.1177/15648265070284S409.
- Background: PubMed 30770543Delaney KM, Guillet R, Fleming RE, Ru Y, Pressman EK, Vermeylen F, Nemeth E, O'Brien KO. Umbilical Cord Serum Ferritin Concentration is Inversely Associated with Umbilical Cord Hemoglobin in Neonates Born to Adolescents Carrying Singletons and Women Carrying Multiples. J Nutr. 2019 Mar 1;149(3):406-415. doi: 10.1093/jn/nxy286.
- BackgroundBernhardt 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dalia G. Mahran, prof study director
prof of public health and community medicine, Faculty of medicine, Assuit university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relation, Mother-Child, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact naglaa A ali (01014616671, naglaaali11995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06871917, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.