Institutional Review Board, Hospital for Special Surgery
May 28, 2008
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
The study objective is to define predictors of outcome in pregnant patients with Systemic Lupus Erythematosus (SLE) and/or anti-phospholipid antibodies (APL). During the course of pregnancy, we collect monthly clinical data along with serial blood and urine specimens. As of July 2009, 434 of the expected 700 participants have been enrolled into this multi-center observational study.
Participants must have an unequivocal diagnosis of SLE (satisfying 4 or more American College of Rheumatology criteria for SLE), APL (positive for anti-ß2 GPI, aCL and/or LAC), or both conditions. Additionally, the patient must meet the following criteria:
• Pregnant as defined by positive test for elevated ß-HCG
• Live single intrauterine pregnancy at less than 12 weeks’ gestation
• 18-45 years of age and able to give informed consent, or a minor with parental consent
• Hematocrit greater than 26%
Patients with any of the following criteria are ineligible for participation:
• Prednisone > 20mg/day
• Renal disease:
• Proteinuria > 1000mg/24 hr
• RBC casts
• Serum creatinine >1.2 mg/dl
• Diabetes mellitus (Type I and Type II) antedating pregnancy
• Hypertension BP > 140/90
• Multiple fetal gestations
Marta M. Guerra, M.S.