Hypothyroidism
Conditions
Keywords
preconception, hypothyroidism, neurocognitive development
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.
Interventions
PROCEDURElevothyroxine
Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks.
Sponsors
Shanghai Municipal Science and Technology Commission
Shanghai Municipal Health Bureau
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Offspring neurocognitive assessment at 0-3 yrs | 3 months, 6 months, 1 year, 2 years, 3 years | Peabody scale, Griffith scale |
| Offspring IQ assessment at 0-3 yrs | 3 months, 6 months, 1 year, 2 years, 3 years | Wechsler Preschool Intelligence Scale at 1, 2, 3-year-old |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of neonatal hypothyroid and complications | up to 28 days of birth | neonatal hypothyroid function, NICU rate, neonatal death rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of maternal complications | up to 42 days postpartumn | preeclampsia, GDM, maternal death rate, maternal hemorrhage rate |
Countries
China
Contacts
Primary ContactXiaotian Li, MD, PhD
Backup ContactQiongjie Zhou, MD
Outcome results
None listed