Mothers and Babies at Yorkhill Thyroid Health Cohort

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Giving Children the Best Start in Life: the Mothers and Babies at Yorkhill Thyroid Health

Conditions
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Thyroid Function

Intervention / Treatment
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* Other: observational only


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mothers and babies<br>pregnant mothers (UK resident) and their babies (observational, not an intervention) | Other: observational only<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thyroid function of mothers (measurement of TSH and Tg) | measurement of TSH and Tg | up to 38 week gestation | 
| thyroid function of infant (routine TSH measurement) | routine TSH measurement | Day 4 of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iodine status of mothers (iodine intake and excretion) | iodine status defined by iodine intake and excretion | up to 38 week gestation | 
| Iodine status of infant (iodine intake and excretion) | iodine status defined by iodine intake and excretion | Day 4 of life | 
| Iodine level in hair and breastmilk | measurement of iodine in hair and breastmilk | after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iodine, thyroid, pregnancy, nutrition, diet, TSH