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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Levothyroxin 50ug/d from randomization until delivery
Placebo to levothyroxin
Zhejiang Women's Hospital
Hangzhou, Zhejiang, China
Zhejiang People's Hospital
Hangzhou, Zhejiang, China
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)
Time frame: From the enrollment to the day of delivery after 28+0 weeks of gestation
Ongoing pregnancy at 7 weeks of gestation
ultrasound diagnosis of ongoing pregnancy at 7 weeks of gestation
Time frame: From the day of randomization to the 7 weeks of gestation
Ongoing pregnancy at 12 weeks of gestation
ultrasound diagnosis of ongoing pregnancy at 12 weeks of gestation
Time frame: From the day of randomization to the 12 weeks of gestation
Ongoing pregnancy at 24 weeks of gestation
ultrasound diagnosis of ongoing pregnancy at 24 weeks of gestation
Time frame: From the day of randomization to the 24 weeks of gestation
Miscarriage
pregnancy loss before 20 weeks of gestation
Time frame: From enrollment to 19+6 weeks of gestation
Stillbirth
fetal death delivered beyond 20 weeks of gestation
Time frame: From enrollment to the day of delivery of the dead fetus from 20+0 weeks onward
Ectopic pregnancy
ultrasound diagnosis of ectopic pregnancy
Time frame: From enrollment to the end of treatment up to 20 weeks
Abortion
personal request the termination of pregnancy without medical conditions
Time frame: From enrollment to the day of termination of pregnancy up to 27+6 weeks
Need for cervical cerclage
medically indicated cervical cerclage up to 27+6 weeks of gestation
Time frame: From enrollment to the day of cervical cerlage performed up to 27+6 weeks
Preterm birth
live birth between 28+0 and 36+6 weeks of gestation
Time frame: From enrollment to the day of preterm birth between 28+0 and 36+6 weeks
Gestational age at delivery
Gestational age at delivery
Time frame: up to delivery
Antepartum complications
including: preeclampsia, gestational diabetes, fetal growth restriction
Time frame: From enrollment to the day of delivery, up to 42+0 weeks
Intrapartum complications
including: fetal distress, dystocia, fever
Time frame: up to delivery
Postpartum complications
including: postpartum hemorrhage, infection, fever
Time frame: up to 42 days after childbirth
Neonatal birthweight
the birthweight of the neonate: unit (kg)
Time frame: up to delivery
Neonatal APGAR score
Neonatal APGAR score at 1 and 5 minutes
Time frame: up to 5 minutes after delivery
Neonatal complications
include neonatal breathing disorders, neonatal infections, neonatal asphyxia, neonatal jaundice, NICU admission for any other causes
Time frame: up to 7 days after delivery
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