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.

Study Overview

• Status: Unknown
• Conditions: ¨Maternal Morbidity¨; ¨Perinatal Mortality¨
• Intervention / Treatment: Other: package of 3 interventions

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

• Study Type: Interventional
• Enrollment (Anticipated): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Guatemala
  • Departamento de San Marcos, Guatemala
    • Recruiting
    • Health Centers for vaginal deliveries (CAP)
    • Contact: Edgar E. Kestler, MD; Phone Number: (502) 22301494; Email: ciesar@ciesar.org.gt
    • Sub-Investigator: Dilys Walker, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: package	Other: package of 3 interventions; Emergency Obstetric Care training, social marketing approach and link TBS with public sector services

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
increase the proportion of institutional deliveries in intervention vs. control clusters	Up to 15 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Decrease perinatal death rate in intervention vs. control clinics	Up to 15 months

Collaborators and Investigators

• Sponsor: Hospital San Juan de Dios Guatemala
• Collaborators: World Health Organization
• Investigators: Principal Investigator: Edgar E Kestler, MD, CIESAR; Principal Investigator: Edgar E. Kestler, MD, CIESAR

Publications and helpful links

General Publications

• Walker DM, Holme F, Zelek ST, Olvera-Garcia M, Montoya-Rodriguez A, Fritz J, Fahey J, Lamadrid-Figueroa H, Cohen S, Kestler E. A process evaluation of PRONTO simulation training for obstetric and neonatal emergency response teams in Guatemala. BMC Med Educ. 2015 Jul 24;15:117. doi: 10.1186/s12909-015-0401-7.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: July 25, 2012
• First Submitted That Met QC Criteria: July 30, 2012
• First Posted (Estimate): July 31, 2012

Study Record Updates

• Last Update Posted (Estimate): July 31, 2012
• Last Update Submitted That Met QC Criteria: July 30, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Perinatal Death
• Other Study ID Numbers: GUACTEK01