LIGHT Trial: Levothyroxine for Gestational Hypothyroidism in Recurrent Pregnancy Loss
- Registration Number
- NCT06999278
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm LT4 Levothyroxin 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. Arm Placebo 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.
- Primary Outcome Measures
Name Time Method Live birth after 28 weeks of gestation From the enrollment to the day of delivery after 28+0 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)
- Secondary Outcome Measures
Name Time Method Ongoing pregnancy at 7 weeks of gestation From the day of randomization to the 7 weeks of gestation ultrasound diagnosis of ongoing pregnancy at 7 weeks of gestation
Ongoing pregnancy at 12 weeks of gestation From the day of randomization to the 12 weeks of gestation ultrasound diagnosis of ongoing pregnancy at 12 weeks of gestation
Ongoing pregnancy at 24 weeks of gestation From the day of randomization to the 24 weeks of gestation ultrasound diagnosis of ongoing pregnancy at 24 weeks of gestation
Miscarriage From enrollment to 19+6 weeks of gestation pregnancy loss before 20 weeks of gestation
Stillbirth From enrollment to the day of delivery of the dead fetus from 20+0 weeks onward fetal death delivered beyond 20 weeks of gestation
Ectopic pregnancy From enrollment to the end of treatment up to 20 weeks ultrasound diagnosis of ectopic pregnancy
Abortion From enrollment to the day of termination of pregnancy up to 27+6 weeks personal request the termination of pregnancy without medical conditions
Need for cervical cerclage From enrollment to the day of cervical cerlage performed up to 27+6 weeks medically indicated cervical cerclage up to 27+6 weeks of gestation
Preterm birth From enrollment to the day of preterm birth between 28+0 and 36+6 weeks live birth between 28+0 and 36+6 weeks of gestation
Gestational age at delivery up to delivery Gestational age at delivery
Antepartum complications From enrollment to the day of delivery, up to 42+0 weeks including: preeclampsia, gestational diabetes, fetal growth restriction
Neonatal APGAR score up to 5 minutes after delivery Neonatal APGAR score at 1 and 5 minutes
Neonatal complications up to 7 days after delivery include neonatal breathing disorders, neonatal infections, neonatal asphyxia, neonatal jaundice, NICU admission for any other causes
Intrapartum complications up to delivery including: fetal distress, dystocia, fever
Postpartum complications up to 42 days after childbirth including: postpartum hemorrhage, infection, fever
Neonatal birthweight up to delivery the birthweight of the neonate: unit (kg)
Trial Locations
- Locations (2)
Zhejiang Women's Hospital
🇨🇳HangZhou, Zhejiang, China
Zhejiang People's Hospital
🇨🇳Hangzhou, Zhejiang, China