- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Glasgow, Verenigd Koninkrijk
- Werving
- NHS GGC Community midwifery units
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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mothers and babies
pregnant mothers (UK resident) and their babies (observational, not an intervention)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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thyroid function of mothers (measurement of TSH and Tg)
Tijdsspanne: up to 38 week gestation
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measurement of TSH and Tg
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up to 38 week gestation
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thyroid function of infant (routine TSH measurement)
Tijdsspanne: Day 4 of life
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routine TSH measurement
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Day 4 of life
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Iodine status of mothers (iodine intake and excretion)
Tijdsspanne: up to 38 week gestation
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iodine status defined by iodine intake and excretion
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up to 38 week gestation
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Iodine status of infant (iodine intake and excretion)
Tijdsspanne: Day 4 of life
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iodine status defined by iodine intake and excretion
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Day 4 of life
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Iodine level in hair and breastmilk
Tijdsspanne: after birth
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measurement of iodine in hair and breastmilk
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after birth
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Filiz Cizmecioglu, University of Glasgow
- Studie directeur: Emilie Combet, University of Glasgow
- Hoofdonderzoeker: Jeremy Jones, University of Glasgow
- Hoofdonderzoeker: Malcolm Donaldson, University of Glasgow
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 153466
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