Mothers and Babies at Yorkhill Thyroid Health Cohort

Thyroid Function Clinical Trial

— MABY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02390128
• Other study ID #: 153466
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2014
• Last updated: March 16, 2015
• Start date: January 2015

Study information

• Verified date: March 2015
• Source: University of Glasgow
• Contact: Emilie Combet, PhD
• Phone: +441412018527
• Email: emilie.combetaspray[@]glasgow.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 697
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Function

Intervention

Other:
• observational only

Locations

Country	Name	City	State
United Kingdom	NHS GGC Community midwifery units	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thyroid function of mothers (measurement of TSH and Tg)	measurement of TSH and Tg	up to 38 week gestation	No
Primary	thyroid function of infant (routine TSH measurement)	routine TSH measurement	Day 4 of life	No
Secondary	Iodine status of mothers (iodine intake and excretion)	iodine status defined by iodine intake and excretion	up to 38 week gestation	No
Secondary	Iodine status of infant (iodine intake and excretion)	iodine status defined by iodine intake and excretion	Day 4 of life	No
Secondary	Iodine level in hair and breastmilk	measurement of iodine in hair and breastmilk	after birth	No