Clinical trial NCT06036576: Thyroxine Therapy for Recurrent Pregnancy Loss in Hypothyroid Women
Official title: Thyroid-Stimulating Hormone Levels and Recurrent Pregnancy Loss: Influence of Thyroxine Supplementation on Pregnancy Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Recurrent Early Pregnancy Loss
Thyroid Diseases
Keywords: Miscarriage
Hypothyroidism
Thyroid Stimulating Hormone
Thyroxin
Lead sponsor: Al-Kindy College of Medicine
Sponsor class: OTHER
Collaborators: name: Al-Elwyiah Maternity Teaching Hospital
First posted: 2023-09-14
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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 4.
* Willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pregnancy Success Rate
timeFrame: Assessed at the end of the first trimester (approximately 12 weeks of gestation) for each participant.
Secondary outcomes:
measure: Gestational Age at Delivery
timeFrame: Assessed at the time of delivery for each participant.
measure: Birth Weight
timeFrame: Assessed at the time of delivery for each participant.
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: AL-Elwiyah Maternity Teaching Hospital
Study officials:
affiliation: Al-Kindy College of Medicine
name: Sarah Al-Musawi, C.A.B.O.G
role: STUDY_CHAIR
References: