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

Not Applicable

• Conditions: ¨Maternal Morbidity¨; ¨Perinatal Mortality¨
• Interventions: Other: package of 3 interventions

• Registration Number: NCT01653626
• Lead Sponsor: Hospital San Juan de Dios Guatemala

Brief Summary

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.

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 Timeline

• Status Verified: 2012-07
• Study Start: 2012-07
• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-07-30
• Last Update Submitted: 2012-07-30
• Study First Posted: 2012-07-31
• Last Update Posted: 2012-07-31
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
package	package of 3 interventions	-

Primary Outcome Measures

Name	Time	Method
increase the proportion of institutional deliveries in intervention vs. control clusters	Up to 15 months

Secondary Outcome Measures

Name	Time	Method
Decrease perinatal death rate in intervention vs. control clinics	Up to 15 months

Trial Locations

Locations (1)

Health Centers for vaginal deliveries (CAP); 🇬🇹 Departamento de San Marcos, Guatemala