Thyroxine Therapy for Recurrent Pregnancy Loss in Hypothyroid Women

NCT06036576 | Completed Phase 3

• 1 other identifier: 15 Al-KindyCM
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Early Pregnancy Loss; Thyroid Diseases

Keywords

Miscarriage; Hypothyroidism; Thyroid Stimulating Hormone; Thyroxin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Gestational Age at Delivery

  Assessed at the time of delivery for each participant.

• Birth Weight

  Assessed at the time of delivery for each participant.

Study Arms (2)

Thyroid Stimulating Hormone 2.5-4 mU/L

ACTIVE COMPARATOR

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

Drug: Levothyroxine Pill

Thyroid Stimulating Hormone more than 4 mU/L

ACTIVE COMPARATOR

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

Drug: Levothyroxine Pill

Interventions

Levothyroxine Pill DRUG

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

Also known as: Euthyrox 50 Mcg Tablet, Merck

Thyroid Stimulating Hormone 2.5-4 mU/L; Thyroid Stimulating Hormone more than 4 mU/L

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Kindy College of Medicine: lead
• Al-Elwyiah Maternity Teaching Hospital: collaborator

Study Sites (1)

AL-Elwiyah Maternity Teaching Hospital

Baghdad, 10011, Iraq

Location

MeSH Terms

Conditions

Abortion, Habitual; Thyroid Diseases; Abortion, Spontaneous; Hypothyroidism

Interventions

Thyroxine; Tablets

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Sarah Al-Musawi, C.A.B.O.G

  Al-Kindy College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: March 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: July 20, 2023
• Last Updated: September 14, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)