Mothers and Babies at Yorkhill Thyroid Health Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

697 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

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.

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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.

Conditions

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Thyroid Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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mothers and babies

pregnant mothers (UK resident) and their babies (observational, not an intervention)

observational only

Intervention Type OTHER

Interventions

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observational only

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes