Maternal Iron Deficiency and Childhood Health

NCT06879080 | Recruiting

• 1 other identifier: R24005
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective observational cohort study is to study maternal iron deficiency and iron deficiency anemia and the use of iron supplements in pregnancy and their impact on the health of the offspring and pregnancy outcomes. All women coming to Tampere University Hospital for prenatal checkups and/or labor are recruited to the study. After giving their consent the mothers fill an online questionnaire about about possible maternal anemia and its diagnosis in pregnancy, iron deficiency and its diagnosis in pregnancy, maternal use of iron supplement or folic acid and it´s timing, about possible other chronic disease and their medications during pregnancy, and whether the mother has got intravenous iron infusions in pregnancy. Mothers also give their permit to use their in-and outpatient data from pregnancy until hospital discharge and to follow the health of their offspring from birth until 7 years of age from in- and outpatient records.We aim to recruit 6000 mother-child-pairs. The health of the offspring (growth, diagnoses, medication, possible therapies, need of support at daycare or school) will be followed for the first month, then at 1,5 years, four years and seven years of age from the patient records. In addition to the cohort study, two nested cohort studies will be performed. The aim of the nested cohort studies is to study the correlation of maternal iron status to the iron status of the child. Secondary aim is to evaluate iron biomarkers, especially reticulocyte hemoglobin, and their reliability to interpret neonatal iron status. A 100 mothers with diagnosed iron deficiency and iron supplementation (p.o. or i.v.) in pregnancy, are recruited to Nested cohort 1. For the nested cohort 2, a 100 mothers with diabetes requiring insulin therapy in pregnancy are recruited. Tor these two cohorts, a 100 mothers without iron deficiency or diabetes will be recruited as controls. Iron status of the mother will be tested before delivery from blood sample. The iron status of the offspring will be checked from umbilical blood, at 2 days of age at the same time other lab tests are taken, at eight months and two and five years of age. In addition to the laboratory tests, parents fill up an electronical questionnaire at eight months, two and five years about the nutrition, sleep, behaviour and cognitive and motor skills of their child. The researchers try to find out, whether iron deficiency in pregnancy has long-term effects on the health and development of the offspring, and how the iron status correlates between the mother and the child, and does it have impact on their sleep, behaviour or skills.

Conditions

Iron Deficiency Anaemia in Childbirth; Iron Deficiency; Iron Deficiency in Pregnancy; Iron Deficiency Anemia in Pregnancy; Iron Status

Keywords

iron deficiency, iron deficiency anemia, pregnancy, pregnancy outcomes, health of the offspring

Outcome Measures

Primary Outcomes (1)

• Health of the offspring

  Information about neonatal outcomes recorded as they are recorded to the Finnish Medical Birth Registry are collected from the first 7 days of life. Neonatal health is followed also until 1 month of age or until hospital discharge from in- and outpatient records. At the next follow-up time points: 1.5 years, 4 years and 7 years of age, the information (growth, possible diagnoses, possible medications, need of support at school at 7 years of age), will be collected from the outpatient records at Wellbeing Services County of Pirkanmaa.

  From birth to 7 years of age

Secondary Outcomes (2)

• Maternal pregnancy outcomes

  From pregnancy to the end of postpartum period.

• Iron status of the newborn and it´s impact on the wellbeing of the child

  From birth until 5 years of age

Study Arms (4)

Pregnant women recruited to the study

All pregnant women who come for prenatal visits or for labor to Tampere University Hospital, and have given their informed consent to participate to this study, and filled the electronical questionnaire about the possible iron deficiency, iron deficiency anemia, iron supplementation, folic acid use, and possible intravenous iron infusions given in pregnancy. The exposure of interest is iron deficiency and iron supplementation therapy.

Nested cohort 1

Once the mothers have given their consent to participate this MATILDA study, we identify 100 mothers with ID/IDA, who have used iron supplement and/or given i.v. iron infusions. They are recruited in chronological order inside the bigger cohort for this nested cohort study number 1. The iron status of the mothers will be tested before delivery, and the iron status of the newborn will be followed as described in study description.

Nested cohort 2

Prospective recruitment for the study will be continued for 2 years, and during this period we recruit 100 mothers who have had diabetes and insulin therapy in pregnancy, to this nested cohort study 2 from Tampere University Hospital. They are recruited in chronological order inside the bigger cohort for this nested cohort study number 2. The iron status of the mothers will be tested before delivery, and the iron status of the newborn will be followed as described in study description.

Nested cohort controls

For the nested cohort groups 1 and 2, a 100 mothers without ID/IDA/diabetes will be recruited. The same controls are used for both the nested cohort groups. They are recruited in chronological order inside the bigger cohort for this control group. The iron status of the mothers will be tested before delivery, and the iron status of the newborn will be followed as described in study description.

Eligibility Criteria

• Gender Eligibility Details: The study is about maternal iron deficiency and iron deficicency anemia in pregnancy. People whose biological sex is female are eligible for this study.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population consist of mothers who come for delivery to Tampere University Hospital between Apr 2024 and Dec 2027, and who have given their consent to participate to the study, and their offspring. We aim for 6000 mother-child pairs.

You may qualify if:

• Pregnant
• Can read and write Finnish, Swedish or English

You may not qualify if:

• Illiterate

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, Pirkanmaa, 33520, Finland

RECRUITING

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Laura K Seppälä, MD,PhD

CONTACT

+358444728144; laura.seppala@pirha.fi

Elli Toivonen, MD,PhD

CONTACT

elli.toivonen@tuni.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: April 22, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2034
• Last Updated: March 17, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)