search
Back to results

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

Primary Purpose

¨Maternal Morbidity¨, ¨Perinatal Mortality¨

Status
Unknown status
Phase
Not Applicable
Locations
Guatemala
Study Type
Interventional
Intervention
package of 3 interventions
Sponsored by
Hospital San Juan de Dios Guatemala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ¨Maternal Morbidity¨

Eligibility Criteria

10 Years - 49 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Health Centers for vaginal deliveries (CAP)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

package

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Decrease perinatal death rate in intervention vs. control clinics

Full Information

First Posted
July 25, 2012
Last Updated
July 30, 2012
Sponsor
Hospital San Juan de Dios Guatemala
Collaborators
World Health Organization
search

1. Study Identification

Unique Protocol Identification Number
NCT01653626
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Juan de Dios Guatemala
Collaborators
World Health Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Increase in the proportion of institutional deliveries in intervention vs. control clusters. Decrease perinatal death rate in intervention vrs control clinics

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
¨Maternal Morbidity¨, ¨Perinatal Mortality¨

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
1 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
package
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
package of 3 interventions
Intervention Description
Emergency Obstetric Care training, social marketing approach and link TBS with public sector services
Primary Outcome Measure Information:
Title
increase the proportion of institutional deliveries in intervention vs. control clusters
Time Frame
Up to 15 months
Secondary Outcome Measure Information:
Title
Decrease perinatal death rate in intervention vs. control clinics
Time Frame
Up to 15 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar E Kestler, MD
Organizational Affiliation
CIESAR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edgar E. Kestler, MD
Organizational Affiliation
CIESAR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Centers for vaginal deliveries (CAP)
City
Departamento de San Marcos
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgar E. Kestler, MD
Phone
(502) 22301494
Email
ciesar@ciesar.org.gt
First Name & Middle Initial & Last Name & Degree
Dilys Walker, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26206373
Citation
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.
Results Reference
derived
PubMed Identifier
23517050
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs