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Clinical trialNCT01276782WithdrawnPhase 4Interventional

Levothyroxine in Pregnant SLE Patients

SponsorJohns Hopkins UniversityEnrollment0Systemic Lupus Erythematosus
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Johns Hopkins University

    Baltimore, Maryland, United States

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Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

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Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2011
Primary completion
30 Jun 2011
Completion
30 Jun 2011
Last update posted
10 Sept 2015
Registered enrollment
0
Registry id
NCT01276782

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.