Mothers and Babies at Yorkhill Thyroid Health Cohort

• Conditions: Thyroid Function
• Interventions: Other: observational only

• Registration Number: NCT02390128
• Lead Sponsor: University of Glasgow

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-11-30
• Study Start: 2015-01
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-16
• Last Update Submitted: 2015-03-16
• Study First Posted: 2015-03-17
• Last Update Posted: 2015-03-17
• Primary Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 697

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mothers and babies	observational only	pregnant mothers (UK resident) and their babies (observational, not an intervention)

Primary Outcome Measures

Name	Time	Method
thyroid function of mothers (measurement of TSH and Tg)	up to 38 week gestation	measurement of TSH and Tg
thyroid function of infant (routine TSH measurement)	Day 4 of life	routine TSH measurement

Secondary Outcome Measures

Name	Time	Method
Iodine status of mothers (iodine intake and excretion)	up to 38 week gestation	iodine status defined by iodine intake and excretion
Iodine level in hair and breastmilk	after birth	measurement of iodine in hair and breastmilk
Iodine status of infant (iodine intake and excretion)	Day 4 of life	iodine status defined by iodine intake and excretion

Trial Locations

Locations (1)

NHS GGC Community midwifery units; 🇬🇧 Glasgow, United Kingdom