An observational study in Thyroid Function, sponsored by University of Glasgow. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by University of Glasgow · Observational
This is an observational study in pregnant mothers and their newborn babies. The rationale of the study is to examine early markers of the effects of iodine insufficiency during pregnancy on thyroid stimulating hormone (TSH) and thyroglobulin in mother and baby.
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.
967 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.
This study's planned enrollment of 697 is above the median of 150 across 381 observational studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →University of Glasgow is the lead sponsor of 141 studies on the registry; 20 are open to participants now.
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Pregnant women and their newborn baby
Exclusion Criteria:
pregnant mothers (UK resident) and their babies (observational, not an intervention)
Other: observational only
thyroid function of mothers (measurement of TSH and Tg)
measurement of TSH and Tg
Time frame: up to 38 week gestation
thyroid function of infant (routine TSH measurement)
routine TSH measurement
Time frame: Day 4 of life
Iodine status of mothers (iodine intake and excretion)
iodine status defined by iodine intake and excretion
Time frame: up to 38 week gestation
Iodine status of infant (iodine intake and excretion)
iodine status defined by iodine intake and excretion
Time frame: Day 4 of life
Iodine level in hair and breastmilk
measurement of iodine in hair and breastmilk
Time frame: after birth
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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University of Glasgow