LIGHT Trial: Levothyroxine for Gestational Hypothyroidism in Recurrent Pregnancy Loss

NCT ID: NCT06999278

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-05-31

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.

Conditions

Abortion, Habitual

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm LT4

The intervention will consist of standard treatment with levothyroxine tablets (50ug/day). The treatment will start from the next day after randomization and end at the day of delivery.

Group Type: EXPERIMENTAL

Levothyroxin

Intervention Type: DRUG

Levothyroxin 50ug/d from randomization until delivery

Arm Placebo

The intervention will consist of standard treatment with levothyroxine placebo daily. The treatment will start from the next day after randomization and end at the day of delivery.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to levothyroxin

Interventions

Levothyroxin

Levothyroxin 50ug/d from randomization until delivery

Intervention Type: DRUG

Placebo

Placebo to levothyroxin

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Qiong Luo

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qiong Luo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

luoq@zju.edu.cn

Locations

Zhejiang Women's Hospital

Hangzhou, Zhejiang, China

Zhejiang People's Hospital

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Qiong Luo, Ph.D.

Role: CONTACT

luoq@zju.edu.cn

+86 571 89998819

Zixing Zhong, MSc

Role: CONTACT

zhongzixing@hmc.edu.cn

+86 571 85893328

Facility Contacts

Wen Hu

Role: primary

huwen1116@zju.edu.cn

+86571-87061501

Zixing Zhong, MSc

Role: primary

zhongzixing@hmc.edu.cn

13758145829

References

Dhillon-Smith RK, Middleton LJ, Sunner KK, Cheed V, Baker K, Farrell-Carver S, Bender-Atik R, Agrawal R, Bhatia K, Edi-Osagie E, Ghobara T, Gupta P, Jurkovic D, Khalaf Y, MacLean M, McCabe C, Mulbagal K, Nunes N, Overton C, Quenby S, Rai R, Raine-Fenning N, Robinson L, Ross J, Sizer A, Small R, Tan A, Underwood M, Kilby MD, Boelaert K, Daniels J, Thangaratinam S, Chan SY, Coomarasamy A. Levothyroxine in Women with Thyroid Peroxidase Antibodies before Conception. N Engl J Med. 2019 Apr 4;380(14):1316-1325. doi: 10.1056/NEJMoa1812537. Epub 2019 Mar 23.

Reference Type: BACKGROUND

PMID: 30907987 (View on PubMed)

van Dijk MM, Vissenberg R, Fliers E, van der Post JAM, van der Hoorn MP, de Weerd S, Kuchenbecker WK, Hoek A, Sikkema JM, Verhoeve HR, Broeze KA, de Koning CH, Verpoest W, Christiansen OB, Koks C, de Bruin JP, Papatsonis DNM, Torrance H, van Wely M, Bisschop PH, Goddijn M. Levothyroxine in euthyroid thyroid peroxidase antibody positive women with recurrent pregnancy loss (T4LIFE trial): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2022 May;10(5):322-329. doi: 10.1016/S2213-8587(22)00045-6. Epub 2022 Mar 14.

Reference Type: BACKGROUND

PMID: 35298917 (View on PubMed)

Other Identifiers

IRB-20250069-R

Identifier Type: -

Identifier Source: org_study_id