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
Recruitment status was: Recruiting
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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|
- increase the proportion of institutional deliveries in intervention vs. control clusters [ Time Frame: Up to 15 months ] [ Designated as safety issue: No ]
- Decrease perinatal death rate in intervention vs. control clinics [ Time Frame: Up to 15 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Other: package of 3 interventions
Emergency Obstetric Care training, social marketing approach and link TBS with public sector services
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653626
|Health Centers for vaginal deliveries (CAP)|
|Departamento de San Marcos, Guatemala|
|Principal Investigator:||Edgar E Kestler, MD||CIESAR|
|Principal Investigator:||Edgar E. Kestler, MD||CIESAR|