Lupus Clinical Trials in Oklahoma City, OK
Systemic lupus erythematosis (SLE) is a treatable systemic autoimmune disease in which the body’s immune system attacks the cells and tissue of any part of its own body. As a result of the damage that the immune system does to its own body, the body suffers tissue damage and inflammation, fatigue, malaise and other symptoms. Patients with SLE experience alternating periods of flares (illness) and remissions. Lupus may cause damage to the organs, most commonly the heart, liver, kidneys, skin, blood vessels, lungs and nervous system.
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Lupus presents many risks for pregnant women and their fetuses; there is an increased risk of flare-ups during pregnancy as well as in-utero fetal death caused by lupus-inflicted spontaneous abortions. However, over 70% of babies born to mothers with SLE are born alive and most of these babies are healthy. Pregnant women who experience flare-ups during pregnancy have an increased risk of fetal death. It is highly recommended that women with SLE have various medical check-ups until birth, as well has post birth doctor visits to watch out for flare-ups.
A condition commonly present in lupus patients is anti-phospholipid antibody syndrome (APS or Hughes syndrome), an autoimmune condition caused by antibodies that work against cell-membrane phospholipids. APS causes hyper-coagulation, leading to blood clots (thrombosis) and pregnancy-related issues, namely stillbirth, miscarriage, severe preeclampsia or preterm delivery. In order to decrease the risk of thrombosis and lower the risk of pregnancy-related complications, APS patients usually take anticoagulant medications such as aspirin, warfarin or heparin).
The PROMISSE Study is an observational study taking place in Oklahoma City that researches SLE and APS in pregnancy. More specifically, the PROMISSE Study works to determine proteins that predict pregnancy results in patients with lupus and APS. The PROMISSE Study currently takes place in nine locations, one of which is in Oklahoma City’s top research facility, Oklahoma Medical Research Foundation. The study has already observed over 700 women throughout their pregnancies. The study accumulates accurate statistics by obtaining from each study participant her general patient information, such as age and history of pregnancies, and each patient has blood samples and urinalyses taken at various intervals during pregnancy for clinical study. The PROMISSE Study “Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)” works to determine if predictions of pregnancy outcomes can be determined from specific proteins that, in cases of SLE and APS, may damage healthy organs. Additionally, researchers of this study are working to discover if pregnancy complications can be predicted by high levels of antiangiogenic factors. This study is currently recruiting patients.
Dr. Jane Salmon, PROMISSE Study principal coordinator explained, “Women with lupus can have normal pregnancies when they work together with their doctors. First, they can time conception when flares are not present. Then they can maintain continual, close follow-up to anticipate potential problems.” A significant period of remission prior to pregnancy significantly reduces the risk of flare-ups during pregnancy from about 65% to 7-33%. Increased levels of prolactin and estrogen tend to exacerbate SLE during pregnancy and post birth. Therefore, it is advisable that women with active SLE use contraception and only get pregnant when they have been in remission for a long period of time. Also, it is advisable that women with APS consult their doctors before conceiving in order to identify risks and work to make the best possible prognosis of pregnancy.