Systemic Lupus Erythematosus is an autoimmune disease that affects more women than men, may begin around childbearing age and often requires medication use over time. The illness has also been linked to negative consequences (outcomes) during pregnancy. Whether these poor outcomes are caused by the illness or medication use is not fully known. Only recently have studies begun to appear in the literature. Initial studies suggest that a drug called hydroxychloroquine is safe to use during pregnancy. However, there are more medications used to treat Systemic Lupus Erythematosus. While some medications are not recommended during pregnancy, timing of pregnancy is not always controlled. Thus, understanding consequences of all medications is important. We will utilize the Clinical Research Practice Datalink to evaluate the incidence of poor outcomes that happen during pregnancy in women with systemic lupus erythematosus and compare them to the incidence of these outcomes in healthy women. We will also compare women with Systemic Lupus Erythematosus who take medication while pregnant to those who do not to address the effect of medication on adverse outcomes. Our study results will help will assist patients and physicians with treatment plans during pregnancy.
The objectives of this study are to determine the association of systemic lupus erythematosus (SLE) during pregnancy with adverse outcomes: abruptio placentae; caesarean section; large for gestational age; late intrauterine fetal death/stillbirth; pre-eclampsia; preterm birth; small for gestational age; spontaneous abortion/miscarriage; or termination, and to determine the impact of medication use versus illness in association with these adverse outcomes. In order to address the first objective, a retrospective cohort analysis will be conducted. Women with SLE will be matched 1:4 to women without SLE by age and birth year. Risk ratios and 95% confidence intervals will be reported.
This will also be the first analysis, to our knowledge, using the case-time-control study to address confounding by indication in the systemic lupus erythematosus pregnant population. Outcome will be defined as one of the aforementioned outcomes. The exposure will be medication during pregnancy. Each woman with an adverse outcome (case) will have a risk period and a referent period defined. External controls will be those without said adverse event. They will also have a risk period (defined as “at risk” gestation completed before delivery) and a referent period. Odds ratios will be reported using conditional logistic regression analysis.
Abruptio placentae
Caesarean section
Pre-eclampsia
Large for gestational age
Small for gestational age
Spontaneous abortion
Preterm birth
Termination of pregnancy
Fetal death/stillbirth
Denise Elsasser Dietz - Chief Investigator - Rutgers, The State University of New Jersey
Denise Elsasser Dietz - Corresponding Applicant - Rutgers, The State University of New Jersey
Anne Dilley - Collaborator - Biogen
Demissie Kitaw - Collaborator - Rutgers, The State University of New Jersey
Jeffery (Jeff) Allen - Collaborator - Biogen
Lin Young - Collaborator - Rutgers, The State University of New Jersey
Stephan Schwander - Collaborator - Rutgers, The State University of New Jersey
Susan Eaton - Collaborator - Biogen
Teresa Janevic - Collaborator - Icahn School of Medicine at Mount Sinai
Todd Rosen - Collaborator - Rutgers, The State University of New Jersey
CPRD Mother-Baby Link;HES Admitted Patient Care