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
About this trial
This is an interventional prevention trial for ¨Maternal Morbidity¨
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
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
NCT ID
NCT01653626
First Posted
July 25, 2012
Last Updated
July 30, 2012
Sponsor
Hospital San Juan de Dios Guatemala
Collaborators
World Health Organization
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
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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
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