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

July 25, 2012
July 30, 2012
July 2012
October 2013   (final data collection date for primary outcome measure)
increase the proportion of institutional deliveries in intervention vs. control clusters [ Time Frame: Up to 15 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01653626 on ClinicalTrials.gov Archive Site
Decrease perinatal death rate in intervention vs. control clinics [ Time Frame: Up to 15 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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.

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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • ¨Maternal Morbidity¨
  • ¨Perinatal Mortality¨
Other: package of 3 interventions
Emergency Obstetric Care training, social marketing approach and link TBS with public sector services
Experimental: package
Intervention: Other: package of 3 interventions
Kestler E, Walker D, Bonvecchio A, de Tejada SS, Donner A. A matched pair cluster randomized implementation trail to measure the effectiveness of an intervention package aiming to decrease perinatal mortality and increase institution-based obstetric care among indigenous women in Guatemala: study protocol. BMC Pregnancy Childbirth. 2013 Mar 21;13:73. doi: 10.1186/1471-2393-13-73.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1
December 2013
October 2013   (final data collection date for primary outcome measure)

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
Female
10 Years to 49 Years
No
Not Provided
Guatemala
 
NCT01653626
GUACTEK01
Yes
Edgar Kestler, World Health Organization
Hospital San Juan de Dios Guatemala
World Health Organization
Principal Investigator: Edgar E Kestler, MD CIESAR
Principal Investigator: Edgar E. Kestler, MD CIESAR
Hospital San Juan de Dios Guatemala
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP