LIGHT Trial: Levothyroxine for Gestational Hypothyroidism in Recurrent Pregnancy Loss

Официальное название

LIGHT - Levothyroxine for Isolated Gestational HypoThyroidism in Women With Recurrent Pregnancy Loss: a Multicenter Randomized, Double-blind, Placebo-controlled Trial - a Study Protocol

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Levothyroxin
  Levothyroxin 50ug/d from randomization until delivery
• Препарат Placebo
  Placebo to levothyroxin

Первичные конечные точки

• Live birth after 28 weeks of gestation [Срок оценки: From the enrollment to the day of delivery after 28+0 weeks of gestation]

Вторичные конечные точки (12)

• Ongoing pregnancy at 7 weeks of gestation [Срок оценки: From the day of randomization to the 7 weeks of gestation]
• Ongoing pregnancy at 12 weeks of gestation [Срок оценки: From the day of randomization to the 12 weeks of gestation]
• Ongoing pregnancy at 24 weeks of gestation [Срок оценки: From the day of randomization to the 24 weeks of gestation]
• Miscarriage [Срок оценки: From enrollment to 19+6 weeks of gestation]
• Stillbirth [Срок оценки: From enrollment to the day of delivery of the dead fetus from 20+0 weeks onward]
• Ectopic pregnancy [Срок оценки: From enrollment to the end of treatment up to 20 weeks]
• Abortion [Срок оценки: From enrollment to the day of termination of pregnancy up to 27+6 weeks]
• Need for cervical cerclage [Срок оценки: From enrollment to the day of cervical cerlage performed up to 27+6 weeks]
• Preterm birth [Срок оценки: From enrollment to the day of preterm birth between 28+0 and 36+6 weeks]
• Gestational age at delivery [Срок оценки: up to delivery]
• Antepartum complications [Срок оценки: From enrollment to the day of delivery, up to 42+0 weeks]
• Intrapartum complications [Срок оценки: up to delivery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Zhejiang Women's Hospital — Ханчжоу
• Zhejiang People's Hospital — Ханчжоу

Публикации

• 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. Levothyrox PMID 30907987
• 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 multicen PMID 35298917

Идентификаторы

NCT: NCT06999278 · IRB-20250069-R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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