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NOT YET RECRUITING
NCT06999278
PHASE3

LIGHT Trial: Levothyroxine for Gestational Hypothyroidism in Recurrent Pregnancy Loss

Sponsor: Women's Hospital School Of Medicine Zhejiang University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-06-01

Completion Date

2027-05-31

Last Updated

2025-06-04

Healthy Volunteers

No

Interventions

DRUG

Levothyroxin

Levothyroxin 50ug/d from randomization until delivery

DRUG

Placebo

Placebo to levothyroxin

Locations (2)

Zhejiang Women's Hospital

Hangzhou, Zhejiang, China

Zhejiang People's Hospital

Hangzhou, Zhejiang, China