Status:
NOT_YET_RECRUITING
LIGHT Trial: Levothyroxine for Gestational Hypothyroidism in Recurrent Pregnancy Loss
Lead Sponsor:
Women's Hospital School Of Medicine Zhejiang University
Collaborating Sponsors:
Zhejiang Provincial People's Hospital
Conditions:
Abortion, Habitual
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
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) an...
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 hypot...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06999278
Start Date
June 1 2025
End Date
May 31 2027
Last Update
June 4 2025
Active Locations (2)
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1
Zhejiang Women's Hospital
Hangzhou, Zhejiang, China, 310006
2
Zhejiang People's Hospital
Hangzhou, Zhejiang, China, 310014