- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Detaljert beskrivelse
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
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
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Glasgow, Storbritannia
- Rekruttering
- NHS GGC Community midwifery units
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
mothers and babies
pregnant mothers (UK resident) and their babies (observational, not an intervention)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
thyroid function of mothers (measurement of TSH and Tg)
Tidsramme: up to 38 week gestation
|
measurement of TSH and Tg
|
up to 38 week gestation
|
|
thyroid function of infant (routine TSH measurement)
Tidsramme: Day 4 of life
|
routine TSH measurement
|
Day 4 of life
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Iodine status of mothers (iodine intake and excretion)
Tidsramme: 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)
Tidsramme: Day 4 of life
|
iodine status defined by iodine intake and excretion
|
Day 4 of life
|
|
Iodine level in hair and breastmilk
Tidsramme: after birth
|
measurement of iodine in hair and breastmilk
|
after birth
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Filiz Cizmecioglu, University of Glasgow
- Studieleder: Emilie Combet, University of Glasgow
- Hovedetterforsker: Jeremy Jones, University of Glasgow
- Hovedetterforsker: Malcolm Donaldson, University of Glasgow
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 153466
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