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Open Access Study protocol

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]

Fernando Althabe1*, Pierre Buekens2, Eduardo Bergel1, José M Belizán3, Nora Kropp4, Linda Wright5, Norman Goco4, Nancy Moss5 and for the Guidelines Trial Group

Author Affiliations

1 Perinatal Research Unit (PRU), Montevideo, Uruguay

2 School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA

3 Institute of Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina

4 RTI International, North Carolina, USA

5 Center for Research for Mothers and Children, National Institute of Child Health & Human Development, USA

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BMC Women's Health 2005, 5:4  doi:10.1186/1472-6874-5-4

Published: 11 April 2005

Abstract

Background

A significant proportion of the health care administered to women in Latin American maternity hospitals during labor and delivery has been demonstrated to be ineffective or harmful, whereas effective interventions remain underutilized. The routine use of episiotomies and the failure to use active management of the third stage of labor are good examples.

Methods/Design

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.