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

NCT ID: NCT01653626

Last Updated: 2012-07-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-12-31

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

Conditions

¨Maternal Morbidity¨; ¨Perinatal Mortality¨

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

package

Group Type: EXPERIMENTAL

package of 3 interventions

Intervention Type: OTHER

Emergency Obstetric Care training, social marketing approach and link TBS with public sector services

Interventions

package of 3 interventions

Emergency Obstetric Care training, social marketing approach and link TBS with public sector services

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

Hospital San Juan de Dios Guatemala

OTHER_GOV

Sponsor Role: lead

Responsible Party

Edgar Kestler

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edgar E Kestler, MD

Role: PRINCIPAL_INVESTIGATOR

CIESAR

Edgar E. Kestler, MD

Role: PRINCIPAL_INVESTIGATOR

CIESAR

Locations

Health Centers for vaginal deliveries (CAP)

Departamento de San Marcos, Departamento de Guatemala, Guatemala

Site Status: RECRUITING

Countries

Guatemala

Facility Contacts

Edgar E. Kestler, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 26206373 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23517050 (View on PubMed)

Other Identifiers

GUACTEK01

Identifier Type: -

Identifier Source: org_study_id