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LIGHT Trial: Levothyroxine for Gestational Hypothyroidism in Recurrent Pregnancy Loss
Sponsor: Women's Hospital School Of Medicine Zhejiang University
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
Conditions
Interventions
Levothyroxin
Levothyroxin 50ug/d from randomization until delivery
Placebo
Placebo to levothyroxin
Locations (2)
Zhejiang Women's Hospital
Hangzhou, Zhejiang, China
Zhejiang People's Hospital
Hangzhou, Zhejiang, China