Clustered Trial for Improving Perinatal Care in Uruguay/Argentina
In Latin American countries certain procedures commonly used in obstetrical care (e.g.
episiotomy) have been shown to be ineffective or harmful. This study hypothesizes that
obstetrical procedures can be changed and new guidelines implemented via peer opinion leader
training. It tests an intervention designed to motivate and facilitate health care
professionals’ development through the implementation and maintenance of simple
evidence-based guidelines to increase the use of evidence-based practices by birth
attendants at the hospital level in Argentina and Uruguay. The primary outcomes are the use
of episiotomies and of oxytocin during the third stage of labor; secondary outcomes include
perineal sutures; postpartum hemorrhages; birth attendants’ readiness to change status.
The sample size was based upon a 10% frequency of oxytocin use and 20% use of episiotomies
in the control group. The study hypothesizes a 40% absolute increase in oxytocin use in the
intervention group; a 20% absolute reduction in use of episiotomies in the intervention
group, calculated at a 0.05 significance level with 80% power.
Following baseline data collections in 24 hospitals, 19 hospitals met inclusion criteria in
three urban districts of Argentina and Uruguay and were randomly assigned to an intervention
or control group. Baseline data collection has been completed with a total of 6597 single
vaginal spontaneous births. The 19 hospitals met inclusion criteria with a rate of active
management of third stage of labor under 25% and an episiotomy rate in spontaneous vaginal
deliveries above 20%. Opinion leaders in the intervention hospitals have been identified
and trained to develop evidence-based guidelines that will be diffused by a multifaceted
approach including seminars, academic detailing, reminders, and feedback on utilization
rates. The hospitals in the nonintervention group will continue with their standard
in-service training activities.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Pierre Buekens, MD, PhD
Tulane School of Public Health and Tropical Medicine
United States: Federal Government