Clinical 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
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Matched Pair Cluster-randomized Implementation Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institut
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 Summary:
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
Sponsor: Hospital San Juan de Dios Guatemala
Current Primary Outcome: increase the proportion of institutional deliveries in intervention vs. control clusters [ Time Frame: Up to 15 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Decrease perinatal death rate in intervention vs. control clinics [ Time Frame: Up to 15 months ]
Original Secondary Outcome: Same as current
Information By: Hospital San Juan de Dios Guatemala
Dates:
Date Received: July 25, 2012
Date Started: July 2012
Date Completion: December 2013
Last Updated: July 30, 2012
Last Verified: July 2012
