Levothyroxine in Pregnant SLE Patients

This study has been terminated.
(Withdraw the study because further analysis showed that it would be futile.)
Sponsor:
Collaborators:
New York University School of Medicine
Duke University
University of Chicago
Stanford University
Information provided by (Responsible Party):
Michelle Petri M.D.,MPH, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01276782
First received: January 12, 2011
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Levothyroxine
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Double-Blind Placebo Controlled Trial of Levothyroxine in Pregnant Systemic Lupus Erythematosus (SLE) Patients With Autoimmune Thyroid Disease

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • preterm birth [ Time Frame: Delivery prior to 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Miscarriage [ Time Frame: Loss of fetus before 20 weeks ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: January 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Pregnant SLE
Pregnant SLE patients with autoimmune thyroid antibodies will be randomized to levothyroxine or Placebo
Drug: Levothyroxine
It is FDA approved drug for thyroid disease
Other Name: levothyroxine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All SLE (Systemic Lupus Erythematosus) pregnant women (aged 18 - 45 years) before 14 weeks of gestation, with autoimmune thyroid antibodies

Exclusion Criteria:

  • SLE (Systemic Lupus Erythematosus) patients already on levothyroxine. Those patients discovered to be hypothyroid who need levothyroxine as part of standard of care
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276782

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
New York University School of Medicine
Duke University
University of Chicago
Stanford University
Investigators
Principal Investigator: Michelle Petri, MD MPH Johns Hopkins University
  More Information

No publications provided

Responsible Party: Michelle Petri M.D.,MPH, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01276782     History of Changes
Other Study ID Numbers: NA_00042993
Study First Received: January 12, 2011
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014