Thyroid-Stimulating Hormone Levels and Recurrent Pregnancy Loss: Influence of Thyroxine Supplementation on Pregnancy Outcomes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Pregnancy Success Rate
研究概览
简要总结
The goal of this clinical trial is to investigate the influence of thyroxine supplementation on pregnancy outcomes in women with varying levels of Thyroid-Stimulating Hormone (TSH), who have experienced recurrent pregnancy loss in the first trimester. The main questions it aims to answer are:
- Does thyroxine treatment improve pregnancy outcomes in women with TSH levels between 2.5 mU/L and 4 mU/L?
- Is the effect of thyroxine treatment different in women with TSH levels higher than 4 mU/L?
Participants will be grouped based on their TSH levels, into two groups - those with TSH levels between 2.5 mU/L and 4 mU/L, and those with TSH levels higher than 4 mU/L. They will then be given thyroxine treatment.
Researchers will compare these two groups to see if the pregnancy outcomes differ based on the different TSH levels and thyroxine treatment.
详细描述
This is a prospective clinical trial that aims to investigate the impact of thyroxine supplementation on the outcomes of pregnancies in women who have experienced recurrent pregnancy loss in the first trimester. The study will specifically focus on the role of Thyroid-Stimulating Hormone (TSH) levels in these outcomes.
Participants in the study will include women who have suffered recurrent pregnancy loss in the first trimester and exhibit varying levels of TSH. For the purpose of this research, these participants will be categorized into two groups based on their TSH levels: the first group will consist of women with TSH levels between 2.5 mU/L and 4 mU/L, and the second group will include those with TSH levels higher than 4 mU/L.
All participants will receive thyroxine treatment, with dosages and treatment plans as determined by their respective healthcare providers. The main purpose of this trial is to examine two key questions:
Does thyroxine treatment lead to improved pregnancy outcomes in women with TSH levels between 2.5 mU/L and 4 mU/L? How does the effect of thyroxine treatment on pregnancy outcomes differ in women with TSH levels higher than 4 mU/L? The primary outcomes of interest in this study will be pregnancy success rates, defined as a viable pregnancy beyond the first trimester. Secondary outcomes might include measurements such as gestational age at delivery, birth weight, and any complications that may arise during pregnancy.
This trial aims to provide valuable insights into the potential benefits of thyroxine treatment for women with varying levels of TSH who have experienced recurrent pregnancy loss. The results could contribute to the development of more effective treatment protocols and ultimately improve pregnancy outcomes for these women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •Women aged 18 to 40 years old.
- •Diagnosis of recurrent pregnancy loss, defined as two or more pregnancy losses in the first trimester.
- •Confirmed thyroid function test results with TSH levels either between 2.5 and 4 or higher than
- •Willing and able to give informed consent for participation in the study.
排除标准
- •Women who are currently taking thyroid medication before the study starts.
- •Presence of other causes of recurrent pregnancy loss such as antiphospholipid syndrome, uterine abnormalities, genetic/chromosomal disorders, etc.
- •Presence of other severe chronic diseases like heart disease, kidney disease, uncontrolled diabetes, etc.
- •Known allergy or intolerance to thyroxine.
研究组 & 干预措施
Thyroid Stimulating Hormone 2.5-4 mU/L
This arm consists of participants who have experienced recurrent pregnancy loss in the first trimester and have TSH levels ranging between 2.5 mU/L and 4 mU/L. These participants will receive levothyroxine treatment of 1.6 micrograms per kg per day
干预措施: Levothyroxine Pill (Drug)
Thyroid Stimulating Hormone more than 4 mU/L
This arm consists of participants who have experienced recurrent pregnancy loss in the first trimester and have TSH levels more than 4 mU/L. These participants will receive levothyroxine treatment of 1.6 micrograms per kg per day
干预措施: Levothyroxine Pill (Drug)
结局指标
主要结局
Pregnancy Success Rate
时间窗: Assessed at the end of the first trimester (approximately 12 weeks of gestation) for each participant.
The primary outcome measure will be the rate of successful pregnancies, defined as a viable pregnancy beyond the first trimester, among participants in each group. This outcome will be compared between the two groups to determine the impact of thyroxine treatment on successful pregnancies in women with varying levels of TSH.
次要结局
- Gestational Age at Delivery(Assessed at the time of delivery for each participant.)
- Birth Weight(Assessed at the time of delivery for each participant.)