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.
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.
Parallel
Levothyroxin
DrugLevothyroxin 50ug/d from randomization until delivery
Placebo
DrugPlacebo to levothyroxin
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)
Ongoing pregnancy at 7 weeks of gestation
ultrasound diagnosis of ongoing pregnancy at 7 weeks of gestation
Ongoing pregnancy at 12 weeks of gestation
ultrasound diagnosis of ongoing pregnancy at 12 weeks of gestation
Ongoing pregnancy at 24 weeks of gestation
ultrasound diagnosis of ongoing pregnancy at 24 weeks of gestation
Miscarriage
pregnancy loss before 20 weeks of gestation
Adverse outcomes related to levothyroxine treatment
unexpected medical event in a patient or clinical trial participant receiving a pharmaceutical product, which may not necessarily be causally related to the treatment
Click on the lead sponsor to view all of their trials.
Women's Hospital School Of Medicine Zhejiang University
Lead sponsor
Zhejiang Provincial People's Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
