Thyroxine Therapy for Recurrent Pregnancy Loss in Hypothyroid Women

Thyroid Diseases Clinical Trial

Official title:

Thyroid-Stimulating Hormone Levels and Recurrent Pregnancy Loss: Influence of Thyroxine Supplementation on Pregnancy Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06036576
• Other study ID #: 15 Al-KindyCM
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2022
• Est. completion date: July 20, 2023

Study information

• Verified date: February 2022
• Source: Al-Kindy College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: July 20, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Fetal Death
• Recurrence
• Recurrent Early Pregnancy Loss
• Thyroid Diseases

Intervention

Drug:
• Levothyroxine Pill
all participants will receive levothyroxine treatment of 1.6 micrograms per kg per day early in the morning on empty stomach.

Locations

Country	Name	City	State
Iraq	AL-Elwiyah Maternity Teaching Hospital	Baghdad

Sponsors (2)

Lead Sponsor	Collaborator
Al-Kindy College of Medicine	Al-Elwyiah Maternity Teaching Hospital

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Success Rate	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.	Assessed at the end of the first trimester (approximately 12 weeks of gestation) for each participant.
Secondary	Gestational Age at Delivery	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.	Assessed at the time of delivery for each participant.
Secondary	Birth Weight	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.	Assessed at the time of delivery for each participant.