Mothers and Babies at Yorkhill Thyroid Health Cohort (MABY)

March 16, 2015 updated by: Emilie Combet, University of Glasgow

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

697

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom
        • Recruiting
        • NHS GGC Community midwifery units

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women and their newborn baby

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mothers and babies
pregnant mothers (UK resident) and their babies (observational, not an intervention)
Other: observational only

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Collaborators

NHS Greater Glasgow and Clyde

Investigators

  • Principal Investigator: Filiz Cizmecioglu, University of Glasgow
  • Study Director: Emilie Combet, University of Glasgow
  • Principal Investigator: Jeremy Jones, University of Glasgow
  • Principal Investigator: Malcolm Donaldson, University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

November 30, 2014

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 153466

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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