Thyroxine Therapy for Recurrent Pregnancy Loss in Hypothyroid Women

NCT ID: NCT06036576

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-07-20

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.

Conditions

Recurrent Early Pregnancy Loss; Thyroid Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Levothyroxine Pill

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Levothyroxine Pill

Intervention Type: DRUG

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

Interventions

Levothyroxine Pill

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

Intervention Type: DRUG

Other Intervention Names

Euthyrox 50 Mcg Tablet, Merck

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Elwyiah Maternity Teaching Hospital

UNKNOWN

Sponsor Role: collaborator

Al-Kindy College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Al-Musawi, C.A.B.O.G

Role: STUDY_CHAIR

Al-Kindy College of Medicine

Locations

AL-Elwiyah Maternity Teaching Hospital

Baghdad, , Iraq

Countries

Iraq

Other Identifiers

15 Al-KindyCM

Identifier Type: -

Identifier Source: org_study_id