The last two decades have witnessed an explosion of new research documenting the deleterious
impact that thyroid disease has on pregnancy and the postpartum period, in relation to
miscarriage preterm delivery intelligence quotient of the unborn child and health of the
mother postpartum. Both subclinical hypothyroidism and thyroid antibody positivity in
euthyroid women have been associated with miscarriage and preterm delivery. Approximately 5%
of all pregnant women have a thyroid disorder. both spontaneous miscarriage and preterm
delivery.
Systemic lupus erythematosus (SLE), an autoimmune disorder of unknown etiology, has also been
documented to negatively impact pregnancy. Women with Systemic lupus erythematosus (SLE)have
increased rates of miscarriage and preterm delivery. Women with Systemic lupus erythematosus
(SLE) also have increased rates of hypothyroidism and autoimmune thyroid disease (AITD,
defined as the presence of thyroid antibodies with or without thyroid dysfunction). Preterm
delivery (PTD), defined as birth prior to 37 weeks gestation, is the leading cause of
neonatal mortality and morbidity in the United States. Although risk factors for preterm
delivery exist, the majority of women have no known risk factors. Recently, both
hypothyroidism and autoimmune thyroid disease have also been linked to preterm delivery.
Given the increased prevalence of negative outcomes documented in pregnant women with thyroid
disease, and the increased rates of hypothyroidism and Autoimmune thyroid disease in women
with Systemic lupus erythematosus (SLE), the investigators determined that Autoimmune thyroid
disease was associated with both preterm delivery and miscarriage. This has led to this
application to begin a pilot randomized clinical trial of thyroxine in autoimmune thyroid
disease in systemic lupus erythematosus pregnancy.
Phase:
Phase 4
Details
Lead Sponsor:
Johns Hopkins University
Collaborators:
Duke University New York University School of Medicine NYU Langone Health Stanford University University of Chicago