Preconceptional Thyroid Screening and Childhood Nerocognitive Function

Study Overview
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Brief Summary
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To assess the effect of universal preconception hypothyroidism for maternal pregnancy outcome, and 0-3yrs offspring neurocognitive ability and IQ score.

Detailed Description
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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.

Official Title
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Preconceptional Thyroid Screening and Childhood Nerocognitive Function

Conditions
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Hypothyroidism

Intervention / Treatment
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* Procedure: levothyroxine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: preconception<br>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 | Procedure: levothyroxine<br>* Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks.<br>|
| Active Comparator: early conception<br>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 | Procedure: levothyroxine<br>* Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks.<br>|
| Placebo Comparator: late conception<br>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 | Procedure: levothyroxine<br>* Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Offspring neurocognitive assessment at 0-3 yrs | Peabody scale, Griffith scale | 3 months, 6 months, 1 year, 2 years, 3 years | 
| Offspring IQ assessment at 0-3 yrs | Wechsler Preschool Intelligence Scale at 1, 2, 3-year-old | 3 months, 6 months, 1 year, 2 years, 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of neonatal hypothyroid and complications | neonatal hypothyroid function, NICU rate, neonatal death rate | up to 28 days of birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preconception, hypothyroidism, neurocognitive development