Preconceptional Thyroid Screening and Childhood Nerocognitive Function
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Offspring neurocognitive assessment at 0-3 yrs
研究概览
简要总结
To assess the effect of universal preconception hypothyroidism for maternal pregnancy outcome, and 0-3yrs offspring neurocognitive ability and IQ score.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Preconceptional group：TSH ≥ 97.5%th and/or FT4 ≤ 2.5%th
- •those who can obey the rules of this study and assign the consent
排除标准
- •age: less than 18 or more than 55
- •multiple pregnancy
- •thyroid tumor disease history
- •those who cannot obey the rules of this study
研究组 & 干预措施
late conception
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
干预措施: levothyroxine (Procedure)
early conception
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
干预措施: levothyroxine (Procedure)
preconception
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
干预措施: levothyroxine (Procedure)
结局指标
主要结局
Offspring neurocognitive assessment at 0-3 yrs
时间窗: 3 months, 6 months, 1 year, 2 years, 3 years
Peabody scale, Griffith scale
Offspring IQ assessment at 0-3 yrs
时间窗: 3 months, 6 months, 1 year, 2 years, 3 years
Wechsler Preschool Intelligence Scale at 1, 2, 3-year-old
次要结局
- Incidence of neonatal hypothyroid and complications(up to 28 days of birth)
研究者
Xiaotian Li
Vice president, Cheif of Obstetrics Department, Obstetrics and Gynecology Hospital
Fudan University