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ClinicalTrials.gov ID

NCT06999278

Lead Sponsor

Women's Hospital School Of Medicine Zhejiang UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

200Estimated

Last Update Posted

Jun 4, 2025Actual

Start Date

Jun 1, 2025Estimated

Primary Completion Date

Apr 30, 2027Estimated

Completion Date

May 31, 2027Estimated

Official Title

LIGHT - Levothyroxine for Isolated Gestational HypoThyroidism in Women With Recurrent Pregnancy Loss: a Multicenter Randomized, Double-blind, Placebo-controlled Trial - a Study Protocol

Brief Summary

The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether levothyroxine supplement improves pregnancy outcomes in women with recurrent pregnancy loss (RPL) and isolated maternal hypothyroidism (IMH).

The main questions it aims to answer are:

Does levothyroxine increase the live birth rate after 24 weeks of gestation? Does levothyroxine improve secondary outcomes such as ongoing pregnancy rates, reduce the incidence of pregnancy loss, or influence maternal and neonatal complications?

Researchers will:

Compare the levothyroxine treatment group (50 µg/day) to the placebo group to assess the impact of the intervention on live birth rates and other pregnancy outcomes.

Participants will:

Be randomly assigned to receive either levothyroxine or a placebo. Take the assigned treatment daily starting from enrollment until the end of pregnancy.

Undergo routine follow-up visits to monitor pregnancy progress and outcomes. This trial seeks to determine whether routine levothyroxine supplementation can improve pregnancy outcomes for women with RPL and IMH.

Detailed Description

Investigators will perform a multi-center, randomized, placebo, double-blind clinical trial of levothyroxine (LT4) in patients aged between 18 years and 40 yearls who are diagnosed with isolated hypothyroxemia (defined as lower FT4 level with normal TSH) and have a previous history of recurrent miscarriages (defined as two or more pregnancy loss). Investigators will assess the effects of standard dose of 50ug/d levothyroxine therapy from the day after randomization to the day of delivery on the pregnancy outcomes, including live birth, neonatal complications, and adverse pregnancy outcomes, etc.

• Abortion, Habitual

• Levothyroxin
• Placebo

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• women with singleton pregnancy
• women with a history of recurrent pregnancy loss (defined as two or more pregnancy loss before 20wks)
• women diagnosed with isolated maternal hypothyroidism (defined as isolated lower level of FT4 with normal TSH levels) in the current pregnancy before 20wks

Exclusion Criteria:

• patients with known thyroid disorders
• patients with antiphospholipid syndrome or other autoimmune conditions
• patients with contraindications to levothyroxine (e.g., acute cardiac arrest, acute pancreatitis, acute myocarditis)
• patients attending other ongoing clinical trials or unwilling to participate.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Women's Hospital School Of Medicine Zhejiang UniversityOTHER

Collaborators

Zhejiang Provincial People's HospitalOTHER

zhongzixing@hmc.edu.cn13758145829