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临床试验/NCT03391154
NCT03391154已完成3 期

Efficacy of Low Dose Levothyroxine During Pregnancy

Ain Shams University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
180
试验地点
1
主要终点
1st trimester miscarriage

研究概览

简要总结

the effect using low dose levo thyroxine in pregnant females with TSH level more than 2.5 mU/L in the first trimester on pregnancy outcome

详细描述

the study aim to detect the effect of low dose levothyroxine 50 ug on pregnant females and compare it with others receiving placebo

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • females with TSH more than 2.5 mU/L and less than 4 mU/L after biochemical diagnosis of pregnancy.

排除标准

  • associated endocrinopathies (PCO/ DM/ hyperprolactinemia )
  • associated medical condition (HTN/ chronic kidney disease.
  • history of recurrent pregnancy loss

研究组 & 干预措施

levothyroxine

Active Comparator

100 pregnant female with TSH of> 2.5 mU/L but less than 4 mU/L after biochemical diagnosis of pregnancy will receive 50 ug of levothyroxine (eltroxin 50) aspen,Egypt throughout the pregnancy

干预措施: levothyroxin (Drug)

结局指标

主要结局

1st trimester miscarriage

时间窗: during 1st 13 weeks of pregnancy

1st trimester spontaneous or missed abortion

次要结局

  • adverse pregnancy outcome(last 26 week of gestation)

研究者

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

Radwa Rasheedy Ali

lecturer of obstetrics and gynecology

Ain Shams University

研究点 (1)

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