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Thyroxine Therapy for Recurrent Pregnancy Loss in Hypothyroid Women

Primary Purpose

Recurrent Early Pregnancy Loss, Thyroid Diseases

Status
Completed
Phase
Phase 3
Locations
Iraq
Study Type
Interventional
Intervention
Levothyroxine Pill
Sponsored by
Al-Kindy College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Early Pregnancy Loss focused on measuring Miscarriage, Hypothyroidism, Thyroid Stimulating Hormone, Thyroxin

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • AL-Elwiyah Maternity Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Thyroid Stimulating Hormone 2.5-4 mU/L

Thyroid Stimulating Hormone more than 4 mU/L

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 7, 2023
Last Updated
September 7, 2023
Sponsor
Al-Kindy College of Medicine
Collaborators
Al-Elwyiah Maternity Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06036576
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
July 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Al-Kindy College of Medicine
Collaborators
Al-Elwyiah Maternity Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Early Pregnancy Loss, Thyroid Diseases
Keywords
Miscarriage, Hypothyroidism, Thyroid Stimulating Hormone, Thyroxin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thyroid Stimulating Hormone 2.5-4 mU/L
Arm Type
Active Comparator
Arm Description
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
Arm Title
Thyroid Stimulating Hormone more than 4 mU/L
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Levothyroxine Pill
Other Intervention Name(s)
Euthyrox 50 Mcg Tablet, Merck
Intervention Description
all participants will receive levothyroxine treatment of 1.6 micrograms per kg per day early in the morning on empty stomach.
Primary Outcome Measure Information:
Title
Pregnancy Success Rate
Description
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.
Time Frame
Assessed at the end of the first trimester (approximately 12 weeks of gestation) for each participant.
Secondary Outcome Measure Information:
Title
Gestational Age at Delivery
Description
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.
Time Frame
Assessed at the time of delivery for each participant.
Title
Birth Weight
Description
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.
Time Frame
Assessed at the time of delivery for each participant.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Al-Musawi, C.A.B.O.G
Organizational Affiliation
Al-Kindy College of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
AL-Elwiyah Maternity Teaching Hospital
City
Baghdad
ZIP/Postal Code
10011
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

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Thyroxine Therapy for Recurrent Pregnancy Loss in Hypothyroid Women

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