Clustered Trial for Improving Perinatal Care in Uruguay/Argentina


Phase 4
N/A
N/A
Not Enrolling
Both
Episiotomy, Pregnancy

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Trial Information

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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Episiotomies

Principal Investigator

Pierre Buekens, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tulane School of Public Health and Tropical Medicine

Authority:

United States: Federal Government

Study ID:

GN 01

NCT ID:

NCT00070720

Start Date:

September 2003

Completion Date:

December 2006

Related Keywords:

  • Episiotomy
  • Pregnancy
  • 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

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