LIGHT Trial: Levothyroxine for Gestational Hypothyroidism in Recurrent Pregnancy Loss

NCT06999278 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: IRB-20250069-R
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Abortion, Habitual

Keywords

recurrent pregnancy loss; isolated maternal hypothyroidism; levothyroxine; adverse pregnancy outcomes; live birth; neonatal complications

Outcome Measures

Primary Outcomes (1)

• Live birth after 28 weeks of gestation

  Live birth following spontaneous labor or iatrogenic delivery after 28+0 weeks of gestation (196 days from the participant's last menstrual period)

  From the enrollment to the day of delivery after 28+0 weeks of gestation

Secondary Outcomes (16)

• Ongoing pregnancy at 7 weeks of gestation

  From the day of randomization to the 7 weeks of gestation

• Ongoing pregnancy at 12 weeks of gestation

  From the day of randomization to the 12 weeks of gestation

• Ongoing pregnancy at 24 weeks of gestation

  From the day of randomization to the 24 weeks of gestation

• Miscarriage

  From enrollment to 19+6 weeks of gestation

• Stillbirth

  From enrollment to the day of delivery of the dead fetus from 20+0 weeks onward

Other Outcomes (1)

• Adverse outcomes related to levothyroxine treatment

  From enrollment to the end of treatment, up to 40 weeks

Study Arms (2)

Arm LT4

EXPERIMENTAL

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.

Drug: Levothyroxin

Arm Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Levothyroxin DRUG

Levothyroxin 50ug/d from randomization until delivery

Arm LT4

Placebo DRUG

Placebo to levothyroxin

Arm Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women diagnosed with confirmed pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• Zhejiang Provincial People's Hospital: collaborator

Study Sites (2)

Zhejiang Women's Hospital

Hangzhou, Zhejiang, 310006, China

Location

Zhejiang People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

Related Publications (2)

• 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.

  PMID: 30907987 BACKGROUND

• 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.

  PMID: 35298917 BACKGROUND

MeSH Terms

Conditions

Abortion, Habitual

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Qiong Luo, Ph.D.

  luoq@zju.edu.cn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiong Luo, Ph.D.

CONTACT

+86 571 89998819; luoq@zju.edu.cn

Zixing Zhong, MSc

CONTACT

+86 571 85893328; zhongzixing@hmc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and Investigators Both participants and investigators are blinded to the group assignments. Participants receive either levothyroxine (50 µg/day) or a placebo in identical tablets that are indistinguishable in appearance, color, shape, and weight. Investigators administering treatments and assessing outcomes remain unaware of the treatment allocation. Randomization and Allocation Randomization is conducted using a secure web-based system, ensuring a 1:1 allocation ratio to either the levothyroxine or placebo group. The randomization process is stratified by study centers to maintain balance across locations. Packaging and Labeling Study drugs, including the placebo, are packaged and labeled uniformly to prevent any visual or informational clues. Each package contains a unique identification code that corresponds to the randomization list, ensuring proper allocation without revealing the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: This is a multi-center, randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: May 31, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

CN (2)