Pelvic floor disorders including urinary incontinence, pelvic organ prolapse and anal incontinence, are major health issues for women resulting in an 11% lifetime risk of requiring surgery. Women with external anal sphincter defects on ultrasound after their first vaginal delivery who subsequently undergo a second vaginal delivery have a 39% risk of anal incontinence. Our ultimate objective is to conduct the Cesarean After Sphincter Tear (CAST) trial - a multicenter randomized clinical trial that will quantify the effect of planned Cesarean section compared to a trial of vaginal delivery on the risk of developing anal incontinence among women that sustained a 3rd or 4th degree laceration of the anal sphincter during their first deliveries. The data obtained from the full trial will also allow us to more fully characterize the risks and benefits of scheduled Cesarean compared to vaginal delivery in this patient population. The success of such a complex trial depends on the careful development of several critical elements. We propose to use the CAST planning period prior to the launch of the trial to achieve the following specific aims: 1) conduct a patient focus group to better understand issues affecting recruitment and retention; 2) script, produce and evaluate a video decision aid to provide participants with uniform background on the risks and benefits of Cesarean and vaginal birth prior to enrolling in the study; 3) develop and field test a centralized, web-based system for randomization and data entry in collaboration with the UNC General Clinical Research Center; 4) validate the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire for telephone administration; 5) identify and recruit six clinical trial sites in addition to the four sites that have already committed to participating in the CAST Pilot; 6) assemble a Data Safety Monitoring Board from experts in clinical trial monitoring, advocates for pregnant women and leading health care providers in the fields of maternal-fetal medicine and urogynecology; and 7) finalize a comprehensive Manual of Operations including fully refined, field-tested protocol. The upfront investment of time and resources will result in the submission of an efficient and well-designed R01 application that can be implemented in a timely fashion. ? ?
