Improving Perinatal Care in Latin America

Pregnancy Clinical Trial

Official title:

Clustered Trial for Improving Perinatal Care in Uruguay/Argentina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00070720
• Other study ID #: GN 01
• Secondary ID: U01HD040477
• Status: Completed
• Phase: Phase 4
• First received: October 7, 2003
• Last updated: December 16, 2013
• Start date: September 2003
• Est. completion date: December 2006

Study information

• Verified date: December 2013
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21780
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Episiotomy
• Pregnancy

Intervention

Behavioral:
• Opinion Leaders, Academic Detailing, Reminders, and Feedback

Locations

Country	Name	City	State
Uruguay	Hospital de Clinicas	Montevideo

Sponsors (13)

Lead Sponsor

Collaborator

NICHD Global Network for Women's and Children's Health

Bill and Melinda Gates Foundation, Global Network for Women's and Children's Health Research, John E. Fogarty International Center (FIC), Latin American Center for Perinatology, National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), Pan American Health Organization, RTI International, Tulane University School of Public Health and Tropical Medicine, University of North Carolina, Chapel Hill, World Health Organization

Country where clinical trial is conducted

Uruguay, 

References & Publications (2)

Althabe F, Buekens P, Bergel E, Belizán JM, Kropp N, Wright L, Goco N, Moss N; for the Guidelines Trial Group. 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]. BMC Womens Health. 2005 Apr 11;5(1):4. — View Citation

Kropp N, Hartwell T, Althabe F. Episiotomy rates from eleven developing countries. Int J Gynaecol Obstet. 2005 Nov;91(2):157-9. Epub 2005 Oct 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Episiotomies
Primary	Oxytocin use in third stage of labor
Secondary	Perineal sutures
Secondary	Postpartum hemorrhage
Secondary	Birth attendants' readiness to change status

External Links

•   Institute for Clinical Effectiveness and Health Policy (IECS)
•   RTI International
•   Tulane School of Public Health and Tropical Medicine