Thyroid FunctionMABYNCT02390128
Mothers and Babies at Yorkhill Thyroid Health Cohort
An observational study of Thyroid Function, run by University of Glasgow at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thyroid Function
- What is being tested?
- observational only
- How many people
- 697 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women and their newborn baby
Who may be able to join
- Healthy pregnant women
- Able to read, write and speak in English
- Attending a Greater Glasgow and Clyde maternity unit
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jeremy Jones contact
United Kingdom1 site, 1 recruiting
- Recruiting
NHS GGC Community midwifery units
Glasgow
About this study
Official title: 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.
Read the 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:
- 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
- Thyroid Function
- Being tested
- observational only
- Keywords
- iodine, thyroid, TSH, pregnancy, nutrition, diet
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational onlyOther
| Study group | Role | What they receive |
|---|---|---|
| mothers and babies | pregnant mothers (UK resident) and their babies (observational, not an intervention) Receives: Other: observational only |
What is being measured
The primary outcome is the main question the study is designed to answer.
thyroid function of mothers (measurement of TSH and Tg)
measurement of TSH and Tg
Measured: up to 38 week gestation
thyroid function of infant (routine TSH measurement)
routine TSH measurement
Measured: Day 4 of life
Secondary outcomes (3)
Iodine status of mothers (iodine intake and excretion)
iodine status defined by iodine intake and excretion
Measured: up to 38 week gestation
Iodine status of infant (iodine intake and excretion)
iodine status defined by iodine intake and excretion
Measured: Day 4 of life
Iodine level in hair and breastmilk
measurement of iodine in hair and breastmilk
Measured: after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 697 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Responsible party
- Principal investigator, Emilie Combet, University of Glasgow
- Investigators
- Filiz Cizmecioglu, Principal investigator, University of GlasgowEmilie Combet, Study director, University of GlasgowJeremy Jones, Principal investigator, University of GlasgowMalcolm Donaldson, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390128
- Sponsor's protocol ID
- 153466
- Acronym
- MABY
- Status last verified
- Mar 2015
- First submitted
- 30 Nov 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giving Children the Best Start in Life: the Mothers and Babies at Yorkhill Thyroid Health
- ClinicalTrials.gov ID
- NCT02390128
- Acronym / sponsor ID
- MABY / 153466
- Conditions
- Thyroid Function
- Keywords
- iodine, thyroid, TSH, pregnancy, nutrition, diet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 697 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mothers and babies | – | Other: observational onlypregnant mothers (UK resident) and their babies (observational, not an intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women and their newborn baby
Key inclusion criteria (3 listed)
- Healthy pregnant women
- Able to read, write and speak in English
- Attending a Greater Glasgow and Clyde maternity unit
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational only | Other | mothers and babies |
Primary outcome
thyroid function of mothers (measurement of TSH and Tg)
Time frame: up to 38 week gestation
measurement of TSH and Tg
thyroid function of infant (routine TSH measurement)
Time frame: Day 4 of life
routine TSH measurement
3 secondary outcomes
Iodine status of mothers (iodine intake and excretion)
Time frame: up to 38 week gestation
Iodine status of infant (iodine intake and excretion)
Time frame: Day 4 of life
Iodine level in hair and breastmilk
Time frame: after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Jones contact
Filiz Cizmecioglu principal investigator
University of Glasgow
Emilie Combet study director
University of Glasgow
Jeremy Jones principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Function, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie Combet, PhD (+441412018527, emilie.combetaspray@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thyroid function of mothers (measurement of TSH and Tg) (time frame: up to 38 week gestation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.