Levothyroxine in Pregnant SLE Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 21 September 2015
• Main ID: NCT01276782
• Date of registration: 12/01/2011
• Prospective Registration: No
• Primary sponsor: Johns Hopkins University
• Public title: Levothyroxine in Pregnant SLE Patients
• Scientific title: Pilot Double-Blind Placebo Controlled Trial of Levothyroxine in Pregnant Systemic Lupus Erythematosus (SLE) Patients With Autoimmune Thyroid Disease
• Date of first enrolment: January 2011
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01276782
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Michelle Petri, MD MPH
• Affiliation: Johns Hopkins University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Levothyroxine

Primary Outcome(s)

preterm birth [Time Frame: Delivery prior to 36 weeks]

Secondary Outcome(s)

Miscarriage [Time Frame: Loss of fetus before 20 weeks]

Secondary ID(s)

NA_00042993

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Duke University

New York University School of Medicine

Stanford University

University of Chicago