|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Global Network for Women's and Children's Health Research Bill and Melinda Gates Foundation John E. Fogarty International Center (FIC) National Center for Complementary and Alternative Medicine (NCCAM) National Institute of Dental and Craniofacial Research (NIDCR) National Cancer Institute (NCI) RTI International Latin American Center for Perinatology Pan American Health Organization World Health Organization Tulane University School of Medicine University of North Carolina |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00070720 |
Purpose
Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. This study will develop and evaluate an intervention intended to implement two evidence-based practices among birth attendants in Latin America, the selective use of episiotomies and active management of the third stage of labor.
| Condition | Intervention | Phase |
|---|---|---|
|
Episiotomy Pregnancy |
Behavioral: Opinion Leaders, Academic Detailing, Reminders, and Feedback |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Clustered Trial for Improving Perinatal Care in Uruguay/Argentina |
| Estimated Enrollment: | 21780 |
| Study Start Date: | September 2003 |
| Study Completion Date: | December 2006 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria for Hospitals
Hospitals were invited to participate in the study if they fulfill the following criteria:
Exclusion Criteria for Hospitals
Preselected hospitals are performing baseline data collection. According to the results of the analysis of the baseline data collection, hospitals will be excluded if the episiotomy rate is low or the rate of active management of the third stage of labor is high, according to the following cut-off points:
The sample size of the study was increased to allow for exclusions.
Expectant management is defined as “a hands-free policy” during third stage of labor until the placenta is expelled: no use of uterotonics or special maneuvers.
Sampling, Recruitment, and Screening Procedures
Latin American Center for Perinatology (CLAP) coordination team will be responsible for the hospital selection.
The hospitals’ fulfillment of selection criteria will be obtained through a survey of the Heads of the Obstetrical Departments.
Besides the selection criteria, the coordination unit will invite the hospitals to participate according to:
Of particular interest are the characteristics of each preselected hospital regarding the structure of the professional staff, number of deliveries, and clinical guidelines policy.
Contacts and Locations| Uruguay | |
| Hospital de Clinicas | |
| Montevideo, Uruguay | |
| Principal Investigator: | Pierre Buekens, MD, PhD | Tulane School of Public Health and Tropical Medicine |
More Information
| Study ID Numbers: | GN 01, U01 HD040477 |
| Study First Received: | October 7, 2003 |
| Last Updated: | June 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00070720 History of Changes |
| Health Authority: | United States: Federal Government |
|
Behavior change Change in practitioner behavior Episiotomy Active management of third stage of labor Global Network Latin America |
Uruguay Argentina Maternal and child health International Women's health |
