Improving Perinatal Care in Latin America

This study has been completed.
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
Latin American Center for Perinatology
Pan American Health Organization
World Health Organization
School of Public Health and Tropical Medicine-Tulane University
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT00070720
First received: October 7, 2003
Last updated: December 16, 2013
Last verified: December 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Clustered Trial for Improving Perinatal Care in Uruguay/Argentina

Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • Episiotomies
  • Oxytocin use in third stage of labor

Secondary Outcome Measures:
  • Perineal sutures
  • Postpartum hemorrhage
  • Birth attendants' readiness to change status

Estimated Enrollment: 21780
Study Start Date: September 2003
Study Completion Date: December 2006
Detailed Description:

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
Criteria

Inclusion Criteria for Hospitals

Hospitals were invited to participate in the study if they fulfill the following criteria:

  • have an Institutional Review Board (IRB), or existing committee which could serve as such, or have an agreement with an IRB which reviews the research protocols implemented in the hospital;
  • have at least 500 vaginal deliveries per year;
  • do not have an explicit policy for selective episiotomy and for active management of third stage of labor;
  • are located within the study area in Argentina and Uruguay; and
  • agree to participate in the study.

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:

  • Episiotomy rate in spontaneous vaginal deliveries below 20%
  • Rate of active management of third stage of labor over 25%

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:

  • their participation in previous trials coordinated by CLAP,
  • their participation in other trials or research activities, and
  • their location.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070720

Locations
Uruguay
Hospital de Clinicas
Montevideo, Uruguay
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
Latin American Center for Perinatology
Pan American Health Organization
World Health Organization
School of Public Health and Tropical Medicine-Tulane University
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Pierre Buekens, MD, PhD Tulane School of Public Health and Tropical Medicine
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00070720     History of Changes
Other Study ID Numbers: GN 01, U01HD040477
Study First Received: October 7, 2003
Last Updated: December 16, 2013
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
Maternal and child health
Women's health
Behavior change
Change in practitioner behavior
Episiotomy
Active management of third stage of labor
Global Network
Latin America
Uruguay
Argentina
International

ClinicalTrials.gov processed this record on July 20, 2014