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L'essai clinique NCT06879080 (MATILDA) pour Iron Deficiency Anaemia in Childbirth, Carence en fer, Iron Deficiency in Pregnancy, Iron Deficiency Anemia in Pregnancy, Iron Status est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Maternal Iron Deficiency and Childhood Health (MATILDA) 6 000 Basé sur biomarqueurs Observationnel
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L'essai clinique NCT06879080 (MATILDA) est une étude observationnel pour Iron Deficiency Anaemia in Childbirth, Carence en fer, Iron Deficiency in Pregnancy, Iron Deficiency Anemia in Pregnancy, Iron Status. Son statut actuel est : en recrutement. L'étude a débuté le 22 avril 2024 et vise à recruter 6 000 participants. Dirigée par l'Université de Tampere, l'étude devrait être terminée d'ici le 31 décembre 2034. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 17 mars 2025.
Résumé succinct
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 abou...
Afficher plusDescription détaillée
This will be a prospective cohort study in Tampere University hospital and The Wellbeing Services County of Pirkanmaa(Pirha). All pregnant women are recruited to participate to the study once they come to Tampere University Hospital for prenatal visits, for labor and/or at newborn pediatric examination performed by pediatricians usually at 2 days of age.
After giving their online consent the mothers fill up a questi...
Afficher plusTitre officiel
Maternal Iron Deficiency and Childhood Health- a Prospective Cohort Study
Pathologies
Iron Deficiency Anaemia in ChildbirthCarence en ferIron Deficiency in PregnancyIron Deficiency Anemia in PregnancyIron StatusAutres identifiants de l'étude
- MATILDA
- R24005
Numéro NCT
Date de début (réel)
2024-04-22
Dernière mise à jour publiée
2025-03-17
Date de fin (estimée)
2034-12-31
Inscription (estimée)
6 000
Type d'étude
Observationnel
Statut
En recrutement
Mots clés
iron deficiency, iron deficiency anemia, pregnancy, pregnancy outcomes, health of the offspring
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
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 supple...Afficher plus | N/A |
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...Afficher plus | N/A |
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 sta...Afficher plus | N/A |
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. | N/A |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Maternal pregnancy outcomes | Maternal pregnancy complications, delivery type, needed procedures and prescriptions are collected from inpatient records and analysed as 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 | Mother´s iron status (including reticulocyte hemoglobin) and C-reactive protein (CRP), will be tested once setting an i.v. route once they come to the hospital for delivery. The iron status of the newborn (small blood count, ferritin, transferrin receptor, reticulocytes including reticulocyte hemoglobin) and CRP, will be tested from umbilical cord blood. At 2-5 days of age at the same time once they are tested for metabolic screening or taken other laboratory tests, a small blood count and reticulocytes are being controlled. The iron status of the offspring (small blood count, ferritin, transferrin receptor, reticulocytes including reticulocyte hemoglobin) and CRP will also be controlled at 8 months, 2 years and 5 years of age.
At 8 months, 2 and 5 years, the family will be sent an electronical questionnaire with questions about the child´s diet, sleep patterns, cognitive development and behavior. | From birth until 5 years of age |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Enfant, Adulte, Adulte âgé
Sexes éligibles
Femme
Accepte les volontaires en bonne santé
Oui
- Pregnant
- Can read and write Finnish, Swedish or English
- Illiterate
Contact central de l'étude
Contact: Laura K Seppälä, MD,PhD, +358444728144, [email protected]
Contact: Elli Toivonen, MD,PhD, [email protected]
1 Centres de l'étude dans 1 pays
Pirkanmaa
Tampere University Hospital, Tampere, Pirkanmaa, 33520, Finland
Laura K Seppälä, MD,PhD,pediatrician, Contact, +358444728144, [email protected]
Elli Toivonen, MD,PhD, gynecologist, Contact, [email protected]
Laura K Seppälä, MD,PhD,pediatrician, Investigateur principal
Elli Toivonen, MD,PhD,gynecologist, Investigateur associé
Pauliina Rinta-Jaskari, MD,pediatrician, Investigateur associé
Inna Anttila, Medical student,PhD student, Investigateur associé
Pilvi Saltiola, MD,physician, Investigateur associé
En recrutement