Mothers and Babies at Yorkhill Thyroid Health Cohort | NCT02390128

Studies
Mothers and Babies at Yorkhill Thyroid Health Cohort

NCT02390128

Sponsor

University of Glasgow

Status

Unknown status

Last Update Posted

Mar 17, 2015Estimated

Enrollment

697Estimated

Phase

Not provided

Conditions

Thyroid Function

Interventions

observational only

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jan 2017Estimated

Completion Date

Not provided

First Submitted Date

Nov 30, 2014

First Submission Date that Met QC Criteria

Mar 16, 2015

First Posted Date

Mar 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2015

Last Update Posted Date

Mar 17, 2015Estimated

Name	Class
NHS Greater Glasgow and Clyde	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

697Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mothers and babies		pregnant mothers (UK resident) and their babies (observational, not an intervention)	Other: observational only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observational only	Other		mothers and babies

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Iodine status of mothers (iodine intake and excretion)	iodine status defined by iodine intake and excretion	up to 38 week gestation
Iodine status of infant (iodine intake and excretion)	iodine status defined by iodine intake and excretion

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant women and their newborn baby

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emilie Combet, PhD	Contact	+441412018527		emilie.combetaspray@glasgow.ac.uk
Jeremy Jones	Contact			jeremy.jones@glasgow.ac.uk

Overall Officials

Name	Affiliation	Role
Filiz Cizmecioglu	University of Glasgow	Principal Investigator
Emilie Combet	University of Glasgow	Study Director
Jeremy Jones

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NHS GGC Community midwifery units	Recruiting	Glasgow			United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D013959	Thyroid Diseases

Ancestor Terms

ID	Term
D004700	Endocrine System Diseases

Browse Leaves

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Browse Branches

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