Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol.

Background: Clinical studies looking at interventions to optimize pregnancy and long-term outcomes for women with cardiac disease and their babies are inconsistent in their reporting of clinical outcomes, making it difficult to compare results across studies and draw meaningful conclusions. The development of a core outcome set (COS)-a standardized, minimum set of outcomes that must be collected and reported in all studies-is a practical solution to this problem.

Methods/design: We will follow a five-step process in developing a COS for studies on pregnant women with cardiac disease.

Development of a Core Outcome Set for Studies on Obesity in Pregnant Patients (COSSOPP): a study protocol.

Background: Maternal obesity is a risk factor for adverse maternal, fetal, and neonatal events. Numerous clinical trials are currently exploring the effectiveness of antenatal and peripartum interventions in improving pregnancy outcomes that can in future inform clinical practice. However, the heterogeneity in outcome reporting limits our ability to compare outcomes across studies, and there is a lack of stakeholder representation in outcome choice.