T4LIFE RCT Results: Does Levothyroxine Increase Live Birth Rates for Women with Recurrent Pregnancy Loss and Thyroid Peroxidase Antibodies?
BACKGROUND AND PURPOSE:
Women with thyroid peroxidase antibodies (TPO-Ab) have a higher risk of recurrent pregnancy loss, as well as other pregnancy complications
van Dijk et al. (The Lancet Diabetes and Endocrinology, 2022) examined whether levothyroxine increased live birth rates in women who were TPO-Ab positive with recurrent pregnancy loss and otherwise normal thyroid function
International, double-blind, placebo-controlled, phase 3 study
The T4LIFE trial; Netherlands, Belgium and Denmark
18 to 42 years
≥2 pregnancy losses
TSH concentration within the institutional reference range
Exclusion: Antiphospholipid syndrome (lupus anticoagulant, anticardiolipin IgG or IgM antibodies, or β2-glycoprotein-I IgG or IgM antibodies) | Other autoimmune diseases, or thyroid disease
Oral levothyroxine, once daily
Dose based on preconception TSH concentration (range 0.5 to 1.0 μg/kg bodyweight)
1:1 randomization prior to conception
Levothyroxine or placebo was continued until the end of pregnancy
Analysis was by intention to treat
Levothyroxine: 94 women | Placebo: 93 women
The trial was stopped prematurely (prior to predefined study population of 240 women) due to slow recruitment
There was no difference in live birth between the group
RR 1.03 (95% CI, 0.77 to 1.38)
Absolute risk difference 1.6% (95% CI, –12.7 to 15.9)
Adverse events were reported equivalently between the groups, and none were directly related to the study procedure
Levothyroxine supplementation was not associated with an increase in live birth rate for women with recurrent pregnancy loss, normal thyroid function and TPO-Ab
The authors conclude
On the basis of our findings, we do not advise routine use of levothyroxine in women who are TPO-Ab positive with recurrent pregnancy loss and normal thyroid function
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