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

NCT01653626 | Unknown DMC

• 1 other identifier: GUACTEK01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

¨Maternal Morbidity¨; ¨Perinatal Mortality¨

Outcome Measures

Primary Outcomes (1)

• increase the proportion of institutional deliveries in intervention vs. control clusters

  Up to 15 months

Secondary Outcomes (1)

• Decrease perinatal death rate in intervention vs. control clinics

  Up to 15 months

Study Arms (1)

package

EXPERIMENTAL

Other: package of 3 interventions

Interventions

package of 3 interventions OTHER

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

package

Eligibility Criteria

• Age: 10 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital San Juan de Dios Guatemala: lead
• World Health Organization: collaborator

Study Sites (1)

Health Centers for vaginal deliveries (CAP)

Departamento de San Marcos, Departamento de Guatemala, Guatemala

RECRUITING

Related Publications (2)

• 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.

  PMID: 26206373 DERIVED

• 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.

  PMID: 23517050 DERIVED

MeSH Terms

Conditions

Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edgar E Kestler, MD

  CIESAR

  PRINCIPAL INVESTIGATOR

• Edgar E. Kestler, MD

  CIESAR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 31, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

GU (1)