Thyroxine Therapy for Recurrent Pregnancy Loss in Hypothyroid Women
Condition: Recurrent Early Pregnancy Loss; Thyroid Diseases
MeSH terms: Abortion, Spontaneous; Fetal Death; Abortion, Habitual; Thyroid Diseases; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Levothyroxine Pill
Intervention type(s): Drug
Intervention description(s): all participants will receive levothyroxine treatment of 1.6 micrograms per kg per day early in the morning on empty stomach.
Other intervention name(s): Euthyrox 50 Mcg Tablet, Merck
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Miscarriage; Hypothyroidism; Thyroid Stimulating Hormone; Thyroxin