Randomized Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
Estimate the proper thyroid screening method during pregnancy. Evaluate if maternal subclinical hypothyroidism treatment during pregnancy result in improved pregnancy outcome and cognitive function in the children.
详细描述
The investigators conducted a single-blinded trial in which pregnant women at a gestation of less than 12 weeks, usually 6 to 8 weeks, provided blood samples for measurement of thyrotropin, free thyroxine(FT4) and thyroid peroxidase antibody (TPOAb). Women were assigned to a screening group in PUMCH (in which measurements were obtained immediately) or a control group in HMCHH (in which serum was stored and measurements were obtained shortly after delivery). Each group enrolled 1000 pregnant women separately. Women with positive findings in the screening group were given individualized levothyroxine treatment and regular follow-up. Compare the pregnancy outcomes, IQ at 2-3 years of age in children of women with subclinical hypothyroidism between two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All of the pregnant women who receive prenatal care in PUMCH and HMCHH
- •Sign the consent form
- •agree to follow-up the pregnancy outcome and child
排除标准
- •the pregnant women who do not agree to enter the study
研究组 & 干预措施
the control group
The serum will be stored and the measurements will be obtained after the delivery
the thyroid screening group
The thyroid function and antibody will be measured during pregnancy. The subclinical hypothyroidism will be treated individually.
干预措施: thyroid screening (Other)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: 1 year
the number of miscarriage，preeclampsia，gestational diabetes，prererm birth and postpartum hemorrhage
次要结局
未报告次要终点
研究者
Liangkun Ma
associate profesoor
Peking Union Medical College Hospital