Pregnancy and childbirth are important events in a woman’s life. A pregnancy loss can be a devastating experience for a couple, especially for the expectant mother. Women positive for thyroid peroxidase antibodies (TPO-Ab) have a higher risk of recurrent pregnancy loss.
Recurrent pregnancy loss is a heartbreaking condition that affects many women worldwide. It is defined as the loss of two or more pregnancies before the 20th week of gestation. This condition can be caused by various factors, including chromosomal abnormalities, hormonal imbalances, infections, and immune system disorders. One of the most common immune system disorders associated with recurrent pregnancy loss is euthyroid thyroid peroxidase antibody positivity.
Levothyroxine is a medication commonly used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone. However, some studies seemed to show that levothyroxine may also be beneficial for women with euthyroid thyroid peroxidase antibody positivity and a history of recurrent pregnancy loss. Levothyroxine has been shown to reduce the levels of thyroid antibodies, which may help improve pregnancy outcomes in women with this condition. Thus, there was a need to conduct further clinical trials to confirm the effect.
Clinical Trial
This clinical trial aimed to evaluate the effectiveness of levothyroxine in women with euthyroid thyroid peroxidase antibody positivity who had a history of recurrent pregnancy loss.The T4LIFE trial was a multicenter phase 3 clinical trial that involved 187 women with a history of recurrent pregnancy loss and euthyroid thyroid peroxidase antibody positivity. The trial participants were randomly assigned to receive either levothyroxine or a placebo. These doses were given once daily starting before conception and continued till the completion of pregnancy. The primary outcome was live birth, defined as the birth of a living child beyond 24 weeks of gestation.