- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02390128
Mothers and Babies at Yorkhill Thyroid Health Cohort (MABY)
Giving Children the Best Start in Life: the Mothers and Babies at Yorkhill Thyroid Health
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Iodine is a critical component of thyroid hormones, which are essential for normal growth, and brain development, most of the latter occurring during fetal life and in the first three years of life. Maternal dietary iodine is the sole source for fetuses and for exclusively breastfed infants. Recent evidence indicates that the UK female population is not iodine sufficient. Thus a significant proportion of UK pregnant women will also be insufficient in dietary iodine with potential harmful consequences for their babies. We wish to investigate the relationship between maternal iodine status (sufficient versus insufficient) in pregnancy, the mode of neonatal feeding (exclusively breast fed vs exclusively formula fed); and the effect this has on the functioning of the newborn baby's thyroid gland, with provision for later cognitive followup assessment. In order to do this, we will determine:
i) the iodine status of the mother during pregnancy and in the immediate postnatal period (dietary and urinary) and the newborn infant (urinary), ii) the thyroid function of the mother (thyroid stimulating hormone, thyroglobulin, T4 in serum during pregnancy, and thyroid stimulating hormone and thyroglobulin in dried blood spots postpartum) and infant (thyroid stimulating hormone in dried blood spots collected during a routine procedure).
Our hypothesis is that babies whose mothers are iodine insufficient will show higher levels of TSH and thyroglobulin than the babies of iodine sufficient mothers.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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-
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Glasgow, Royaume-Uni
- Recrutement
- NHS GGC Community midwifery units
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Healthy pregnant women
- Able to read, write and speak in English
- Attending a Greater Glasgow and Clyde maternity unit
Exclusion Criteria:
- Abnormal pregnancies.
- Mothers with known thyroid disorders.
- Preterm infants (born before 37 completed weeks).
- Multiple births.
- Infants with postnatal problems such as infection or malformation.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
mothers and babies
pregnant mothers (UK resident) and their babies (observational, not an intervention)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
thyroid function of mothers (measurement of TSH and Tg)
Délai: up to 38 week gestation
|
measurement of TSH and Tg
|
up to 38 week gestation
|
|
thyroid function of infant (routine TSH measurement)
Délai: Day 4 of life
|
routine TSH measurement
|
Day 4 of life
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Iodine status of mothers (iodine intake and excretion)
Délai: up to 38 week gestation
|
iodine status defined by iodine intake and excretion
|
up to 38 week gestation
|
|
Iodine status of infant (iodine intake and excretion)
Délai: Day 4 of life
|
iodine status defined by iodine intake and excretion
|
Day 4 of life
|
|
Iodine level in hair and breastmilk
Délai: after birth
|
measurement of iodine in hair and breastmilk
|
after birth
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Filiz Cizmecioglu, University of Glasgow
- Directeur d'études: Emilie Combet, University of Glasgow
- Chercheur principal: Jeremy Jones, University of Glasgow
- Chercheur principal: Malcolm Donaldson, University of Glasgow
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 153466
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