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Preconceptional Thyroid Screening and Childhood Nerocognitive Function

Primary Purpose

Hypothyroidism

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
levothyroxine
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothyroidism focused on measuring preconception, hypothyroidism, neurocognitive development

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Preconceptional group：TSH ≥ 97.5%th and/or FT4 ≤ 2.5%th
  2. age: 18-55
  3. those who can obey the rules of this study and assign the consent

Exclusion Criteria:

  1. age: less than 18 or more than 55
  2. multiple pregnancy
  3. thyroid tumor disease history
  4. those who cannot obey the rules of this study

Sites / Locations

  • Obstetrics and Gynecology Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

preconception

early conception

late conception

Arm Description

Participants will be included according to their first outpatient visiting time. Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks. Medical records include: a)maternal thyroid function at enrollment; b) Levothyroxine: length, dose, drug adverse effects; c)Early trimester of pregnancy: Down's screening; d)2nd trimester of pregnancy: fetal echocardiography; e)Whole course of pregnancy: maternal complications, maternal blood pressure at each visit, fetal growth; f)Pregnancy outcome: type of delivery, length of labor, type and timing of analgesia/anesthesia, Apgar scores, postpartum hemorrhage, fetal complications; g)Offspring cognitive assessment at 0-3 years old

Participants will be included according to their first outpatient visiting time before 15+6 gestational week. Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks. Medical records include: a)maternal thyroid function at enrollment; b) Levothyroxine: length, dose, drug adverse effects; c)Early trimester of pregnancy: Down's screening; d)2nd trimester of pregnancy: fetal echocardiography; e)Whole course of pregnancy: maternal complications, maternal blood pressure at each visit, fetal growth; f)Pregnancy outcome: type of delivery, length of labor, type and timing of analgesia/anesthesia, Apgar scores, postpartum hemorrhage, fetal complications; g)Offspring cognitive assessment at 0-3 years old

Participants will be included according to their first outpatient visiting time after 16 gestational week. Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks. Medical records include: a)maternal thyroid function at enrollment; b) Levothyroxine: length, dose, drug adverse effects; c)Early trimester of pregnancy: Down's screening; d)2nd trimester of pregnancy: fetal echocardiography; e)Whole course of pregnancy: maternal complications, maternal blood pressure at each visit, fetal growth; f)Pregnancy outcome: type of delivery, length of labor, type and timing of analgesia/anesthesia, Apgar scores, postpartum hemorrhage, fetal complications; g)Offspring cognitive assessment at 0-3 years old

Outcomes

Primary Outcome Measures

Offspring neurocognitive assessment at 0-3 yrs
Peabody scale, Griffith scale
Offspring IQ assessment at 0-3 yrs
Wechsler Preschool Intelligence Scale at 1, 2, 3-year-old

Secondary Outcome Measures

Incidence of neonatal hypothyroid and complications
neonatal hypothyroid function, NICU rate, neonatal death rate

Full Information

First Posted
October 20, 2012
Last Updated
December 7, 2012
Sponsor
Fudan University
Collaborators
Shanghai Municipal Science and Technology Commission, Shanghai Municipal Health Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT01744743
Brief Title
Preconceptional Thyroid Screening and Childhood Nerocognitive Function
Official Title
Preconceptional Thyroid Screening and Childhood Nerocognitive Function
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Shanghai Municipal Science and Technology Commission, Shanghai Municipal Health Bureau

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess the effect of universal preconception hypothyroidism for maternal pregnancy outcome, and 0-3yrs offspring neurocognitive ability and IQ score.
Detailed Description
Epidemic evidence and animal studies suggested that hypothyroidism is related with maternal pregnancy outcome, offspring cognitive ability. Negro's study found improved maternal health in those screened in early trimester; while Lazarus et al. reported no significant offspring IQ score at 3yrs in universal screening in early trimester. Currently, it lacks evidence of universal pre-conception screening for maternal pregnancy outcome and offspring cognitive development, motivation ability, attention. China Governmental Health Department has included thyroid function screening into preconception in 2011. The investigators hypothesize that pre-conception effective treatment may be helpful for decrease possible negative effects on maternal and offspring health, instead of early trimester.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
Keywords
preconception, hypothyroidism, neurocognitive development

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
preconception
Arm Type
Active Comparator
Arm Description
Participants will be included according to their first outpatient visiting time. Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks. Medical records include: a)maternal thyroid function at enrollment; b) Levothyroxine: length, dose, drug adverse effects; c)Early trimester of pregnancy: Down's screening; d)2nd trimester of pregnancy: fetal echocardiography; e)Whole course of pregnancy: maternal complications, maternal blood pressure at each visit, fetal growth; f)Pregnancy outcome: type of delivery, length of labor, type and timing of analgesia/anesthesia, Apgar scores, postpartum hemorrhage, fetal complications; g)Offspring cognitive assessment at 0-3 years old
Arm Title
early conception
Arm Type
Active Comparator
Arm Description
Participants will be included according to their first outpatient visiting time before 15+6 gestational week. Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks. Medical records include: a)maternal thyroid function at enrollment; b) Levothyroxine: length, dose, drug adverse effects; c)Early trimester of pregnancy: Down's screening; d)2nd trimester of pregnancy: fetal echocardiography; e)Whole course of pregnancy: maternal complications, maternal blood pressure at each visit, fetal growth; f)Pregnancy outcome: type of delivery, length of labor, type and timing of analgesia/anesthesia, Apgar scores, postpartum hemorrhage, fetal complications; g)Offspring cognitive assessment at 0-3 years old
Arm Title
late conception
Arm Type
Placebo Comparator
Arm Description
Participants will be included according to their first outpatient visiting time after 16 gestational week. Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks. Medical records include: a)maternal thyroid function at enrollment; b) Levothyroxine: length, dose, drug adverse effects; c)Early trimester of pregnancy: Down's screening; d)2nd trimester of pregnancy: fetal echocardiography; e)Whole course of pregnancy: maternal complications, maternal blood pressure at each visit, fetal growth; f)Pregnancy outcome: type of delivery, length of labor, type and timing of analgesia/anesthesia, Apgar scores, postpartum hemorrhage, fetal complications; g)Offspring cognitive assessment at 0-3 years old
Intervention Type
Procedure
Intervention Name(s)
levothyroxine
Intervention Description
Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks.
Primary Outcome Measure Information:
Title
Offspring neurocognitive assessment at 0-3 yrs
Description
Peabody scale, Griffith scale
Time Frame
3 months, 6 months, 1 year, 2 years, 3 years
Title
Offspring IQ assessment at 0-3 yrs
Description
Wechsler Preschool Intelligence Scale at 1, 2, 3-year-old
Time Frame
3 months, 6 months, 1 year, 2 years, 3 years
Secondary Outcome Measure Information:
Title
Incidence of neonatal hypothyroid and complications
Description
neonatal hypothyroid function, NICU rate, neonatal death rate
Time Frame
up to 28 days of birth
Other Pre-specified Outcome Measures:
Title
Incidence of maternal complications
Description
preeclampsia, GDM, maternal death rate, maternal hemorrhage rate
Time Frame
up to 42 days postpartumn

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preconceptional group：TSH ≥ 97.5%th and/or FT4 ≤ 2.5%th age: 18-55 those who can obey the rules of this study and assign the consent Exclusion Criteria: age: less than 18 or more than 55 multiple pregnancy thyroid tumor disease history those who cannot obey the rules of this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaotian Li, MD, PhD
Phone
862163455050
Email
xiaotianli555@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiongjie Zhou, MD
Phone
862163455050
Email
qj_zhou@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaotian Li, MD, PhD
Organizational Affiliation
Obstetrics and Gynecology Hospital, Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obstetrics and Gynecology Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaotian Li, MD, PhD
Phone
862163455050
Email
xiaotianli555@163.com
First Name & Middle Initial & Last Name & Degree
Qiongjie Zhou, MD
Phone
862163455050
Email
qj_zhou@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32841335
Citation
Zhou Q, Wang C, Xu H, Li X. Impact of Preconception Treatment Initiation for Hypothyroidism on Neurocognitive Function in Children. J Clin Endocrinol Metab. 2020 Nov 1;105(11):dgaa565. doi: 10.1210/clinem/dgaa565.
Results Reference
derived

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Preconceptional Thyroid Screening and Childhood Nerocognitive Function

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