A cluster randomized controlled trial of a behavioral intervention to facilitate the development and implementation of clinical practice guidelines in Latin American maternity hospitals: the Guidelines Trial: Study protocol [ISRCTN82417627]

The aim of this trial is to evaluate the effect of a multifaceted behavioral intervention on the use of two evidence-based birth practices, the selective use of episiotomies and active management of the third stage of labor (injection of 10 International Units of oxytocin). The intervention is based on behavioral and organizational change theories and was based on formative research. Twenty-four hospitals in three urban districts of Argentina and Uruguay will be randomized. Opinion leaders in the 12 intervention hospitals will be identified and trained to develop and implement evidence-based guidelines. They will then disseminate the guidelines using a multifaceted approach including academic detailing, reminders, and feedback on utilization rates. The 12 hospitals in the control group will continue with their standard in-service training activities. The main outcomes to be assessed are the rates of episiotomy and oxytocin use during the third stage of labor. Secondary outcomes will be perineal sutures, postpartum hemorrhages, and birth attendants' opinions.In Latin American maternity hospitals, a significant proportion of the health care administered to women during labor and delivery has been demonstrated to be ineffective or harmful, whereas proven effective interventions are underutilized. For example, routine episiotomy use has been documented to be useless and even harmful [1], yet the episiotomy rate in vaginal births of primiparous women in Latin American hospitals is 92 %. [2]. The caesarean section rate in Latin American countries is above 25% for the region as a whole, resulting in approximately 850,000 unnecessary cesarean sections performed each year [3]. Simultaneously, many of the birth practices verified as beneficial are not routinely used, e.g. active management of the third stage of labor has been proven effective to prevent postpartum hemorrhage, one of the leading causes of maternal deaths in the developing world [4]. In a survey in 19 maternity