Clinical trial NCT02390128: Mothers and Babies at Yorkhill Thyroid Health Cohort
Official title: Giving Children the Best Start in Life: the Mothers and Babies at Yorkhill Thyroid Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Function
Keywords: iodine
thyroid
TSH
pregnancy
nutrition
diet
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: NHS Greater Glasgow and Clyde
First posted: 2015-03-17
Enrollment: 697
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women and their newborn baby

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.

Eligibility criteria: 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.

Primary outcomes:
measure: thyroid function of mothers (measurement of TSH and Tg)
timeFrame: up to 38 week gestation
measure: thyroid function of infant (routine TSH measurement)
timeFrame: Day 4 of life
Secondary outcomes:
measure: Iodine status of mothers (iodine intake and excretion)
timeFrame: up to 38 week gestation
measure: Iodine status of infant (iodine intake and excretion)
timeFrame: Day 4 of life
measure: Iodine level in hair and breastmilk
timeFrame: after birth
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: NHS GGC Community midwifery units
Study officials:
affiliation: University of Glasgow
name: Filiz Cizmecioglu
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Emilie Combet
role: STUDY_DIRECTOR
affiliation: University of Glasgow
name: Jeremy Jones
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Malcolm Donaldson
role: PRINCIPAL_INVESTIGATOR
References: