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临床试验/NCT03663517
NCT03663517已完成不适用

Gestational Age Specific Thyroid Function Reference Range in Hong Kong

Chinese University of Hong Kong0 个研究点目标入组 599 人开始时间: 2014年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
599
主要终点
Change of free triiodothyronine (FT3) during pregnancy

研究概览

简要总结

It has been well accepted that maternal thyroid dysfunction has adverse affects on both mothers and fetuses. However, the dramatical changes during pregnancy make the interpretation of thyroid function test (TFT, i.e. free triiodothyronine [FT3], free thyroxine [FT4] and thyrotropin [TSH]) very difficult. Previous studies have shown that the level of thyroid hormones differs from non-pregnant population and varies from gestational ages. Moreover, studies have shown the agreement among different instrument platforms was quite low. This study is aimed to determine gestational age specific TFT reference ranges of the local pregnant population for all available platforms currently used under Hospital Authority and Department of Health.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Pregnant women receiving pregnancy and postnatal care in the Department of Obstetrics & Gynaecology, Prince of Wales Hospital, Hong Kong

排除标准

  • •Previous history of thyroid dysfunction (hypothyroidism or hyperthyroidism);
  • •Autoimmune disease, particularly those receiving corticosteroid or immunosuppressant: e.g. systemic lupus erythematosus;
  • •Disease associated with thyroid dysfunction: e.g. molar pregnancy

结局指标

主要结局

Change of free triiodothyronine (FT3) during pregnancy

时间窗: At the time of booking for antenatal visit (1st trimester), oral glucose tolerance test (24-32 weeks), admission for delivery (3rd trimester) and a gestational age assigned randomly.

gestational FT3 level

Change of free thyroxine (FT4) during pregnancy

时间窗: At the time of booking for antenatal visit (1st trimester), oral glucose tolerance test (24-32 weeks), admission for delivery (3rd trimester) and a gestational age assigned randomly.

gestational FT4 level

Change of thyrotropin (TSH) during pregnancy

时间窗: At the time of booking for antenatal visit (1st trimester), oral glucose tolerance test (24-32 weeks), admission for delivery (3rd trimester) and a gestational age assigned randomly.

gestational TSH level

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wing Hung Tam

Professor

Chinese University of Hong Kong

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