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A Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala

This study is currently recruiting participants.
Verified July 2012 by Hospital San Juan de Dios Guatemala
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Edgar Kestler, World Health Organization
ClinicalTrials.gov Identifier:
NCT01653626
First received: July 25, 2012
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  Purpose

A matched pair cluster-randomized trial of this intervention package will be conducted in four rural and indigenous districts (Huehuetenango, Quiche, Alta Verapaz and San Marcos) of the Republic of Guatemala, using the health clinic as the unit of randomization. No external intervention is planned for control facilities, although enhanced monitoring, surveillance and data collection will occur throughout the study in all facilities in the four districts.

The package includes 3 interventions: 1) To train health care professionals in emergency obstetric and perinatal care using an innovative high-fidelity, low-tech, in situ, multidisciplinary simulation training curriculum (PRONTO); 2) To design and implement a social marketing strategy that promotes institution-based delivery; and 3) To integrate the role of obstetric nurse and professional midwife in intervention communities to act as liaisons between traditional birth attendants (TBA) and public health units. A fourth, cross-cutting component involves ongoing analysis, monitoring, surveillance and evaluation to strengthen information systems and monitor perinatal outcomes throughout the two years of the study.


Condition Intervention
¨Maternal Morbidity¨
¨Perinatal Mortality¨
 Other: package of 3 interventions

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Matched Pair Cluster-randomized Implementation Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala

Further study details as provided by Hospital San Juan de Dios Guatemala:

Primary Outcome Measures:
  • increase the proportion of institutional deliveries in intervention vs. control clusters [ Time Frame: Up to 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease perinatal death rate in intervention vs. control clinics [ Time Frame: Up to 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: package Other: package of 3 interventions
Emergency Obstetric Care training, social marketing approach and link TBS with public sector services

Detailed Description:

Overall goal

To evaluate the impact of a package of three interventions aiming to increase institution-based delivery and improve emergency obstetric and neonatal care on perinatal mortality, in the four districts with the highest maternal mortality ratios in Guatemala.

Specific objectives

  • Measure the impact of this intervention package on perinatal mortality rates.
  • Measure the impact of this intervention package on the proportion of institution-based delivery among study facilities.
  • Evaluate the processes and success of implementing this combined package of interventions by analyzing process indicators related to the intervention element designed to improve emergency obstetric and neonatal care (PRONTO: emergency obstetric and perinatal training program).

Primary outcome of interest:

  1. Increase in the proportion of institutional deliveries in intervention vs. control clusters.
  2. Decrease perinatal death rate in intervention vrs control clinics
  Eligibility

Ages Eligible for Study:   10 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • rural women
  • indigenous
  • poor
  • Facilities at rural area
  • Clinic attending vaginal deliveries

Exclusion Criteria:

  • Facilities considered too close geographically to risk contamination of intervention to control facilities
  • Clinics visits by pregnant women who present to intervention or control clinics for reasons other that an obstetric event
  • Clinic or hospital visits by women who present to intervention or control clinics in the post partum period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653626

Locations
Guatemala
Health Centers for vaginal deliveries (CAP) Recruiting
Departamento de San Marcos, Guatemala
Contact: Edgar E. Kestler, MD     (502) 22301494     ciesar@ciesar.org.gt    
Sub-Investigator: Dilys Walker, MD            
Sponsors and Collaborators
Hospital San Juan de Dios Guatemala
World Health Organization
Investigators
Principal Investigator: Edgar E Kestler, MD CIESAR
Principal Investigator: Edgar E. Kestler, MD CIESAR
  More Information

No publications provided by Hospital San Juan de Dios Guatemala

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Edgar Kestler, Director, World Health Organization
ClinicalTrials.gov Identifier: NCT01653626     History of Changes
Other Study ID Numbers: GUACTEK01
Study First Received: July 25, 2012
Last Updated: July 30, 2012
Health Authority: Geneva: 'World Health Organization'

ClinicalTrials.gov processed this record on May 16, 2013