Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation
研究概览
简要总结
Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy.
详细描述
Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with a prior diagnosis of hypothyroidism, currently receiving levothyroxine therapy
- •less than 8 weeks pregnant
排除标准
- •cardiac disease, renal failure
- •not euthyroid biochemically within 6 months pre-pregnancy
研究组 & 干预措施
2 tablet increase
Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
干预措施: Anticipatory dose increase of levothyroxine (Drug)
2 tablet increase
Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
干预措施: levothyroxine (Drug)
3 tablet increase
Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
干预措施: Anticipatory dose increase of levothyroxine (Drug)
3 tablet increase
Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
干预措施: levothyroxine (Drug)
结局指标
主要结局
Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation
时间窗: 9 months
The proportion of patients in each treatment arm euthyroid through gestation
次要结局
- the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State(9 months)
- Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.(9 months)
研究者
Erik K. Alexander
Associate Professor of Medicine
Brigham and Women's Hospital