Thyroxine Therapy for Recurrent Pregnancy Loss in Hypothyroid Women

Phase 3

Completed

• Conditions: Thyroid Diseases; Recurrent Early Pregnancy Loss
• Interventions: Drug: Levothyroxine Pill

• Registration Number: NCT06036576
• Lead Sponsor: Al-Kindy College of Medicine

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.

Study Timeline

• Status Verified: 2022-02
• Study Start: 2022-03-01
• Primary Completion: 2023-05-30
• Study Completion: 2023-07-20
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thyroid Stimulating Hormone more than 4 mU/L	Levothyroxine Pill	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
Thyroid Stimulating Hormone 2.5-4 mU/L	Levothyroxine Pill	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

Primary Outcome Measures

Name	Time	Method
Pregnancy Success Rate	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.

Secondary Outcome Measures

Name	Time	Method
Gestational Age at Delivery	Assessed at the time of delivery for each participant.	The gestational age at delivery will be recorded and compared between the two groups. This metric provides information about whether thyroxine treatment affects the timing of delivery in this population.
Birth Weight	Assessed at the time of delivery for each participant.	The birth weight of the baby will be measured and compared between the two groups. This can provide further information on the potential effects of thyroxine treatment on pregnancy outcomes.

Trial Locations

Locations (1)

AL-Elwiyah Maternity Teaching Hospital; 🇮🇶 Baghdad, Iraq