- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
-
Glasgow, Storbritannien
- Rekrytering
- NHS GGC Community midwifery units
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
mothers and babies
pregnant mothers (UK resident) and their babies (observational, not an intervention)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
thyroid function of mothers (measurement of TSH and Tg)
Tidsram: up to 38 week gestation
|
measurement of TSH and Tg
|
up to 38 week gestation
|
|
thyroid function of infant (routine TSH measurement)
Tidsram: Day 4 of life
|
routine TSH measurement
|
Day 4 of life
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Iodine status of mothers (iodine intake and excretion)
Tidsram: 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)
Tidsram: Day 4 of life
|
iodine status defined by iodine intake and excretion
|
Day 4 of life
|
|
Iodine level in hair and breastmilk
Tidsram: after birth
|
measurement of iodine in hair and breastmilk
|
after birth
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Filiz Cizmecioglu, University of Glasgow
- Studierektor: Emilie Combet, University of Glasgow
- Huvudutredare: Jeremy Jones, University of Glasgow
- Huvudutredare: Malcolm Donaldson, University of Glasgow
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 153466
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .