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

Abstract

BackgroundMaternal and perinatal mortality continue to be a high priority problem on the health agendas of less developed countries. Despite the progress made in the last decade to quantify the magnitude of maternal mortality, few interventions have been implemented with the intent to measure impact directly on maternal or perinatal deaths. The success of interventions implemented in less developed countries to reduce mortality has been questioned, in terms of the tendency to maintain a clinical perspective with a focus on purely medical care separate from community-based approaches that take cultural and social aspects of maternal and perinatal deaths into account. Our innovative approach utilizes both the clinical and community perspectives; moreover, our study will report the weight that each of these components may have had on reducing perinatal mortality and increasing institution-based deliveries.Methods/DesignA matched pair cluster-randomized trial will be conducted in clinics in four rural indigenous districts with the highest maternal mortality ratios in Guatemala. The individual clinic will serve as the unit of randomization, with 15 matched pairs of control and intervention clinics composing the final sample. Three interventions will be implemented in indigenous, rural and poor populations: a simulation training program for emergency obstetric and perinatal care, increased participation of the professional midwife in strengthening the link between traditional birth attendants (TBA) and the formal health care system, and a social marketing campaign to promote institution-based deliveries. No external intervention is planned for control clinics, although enhanced monitoring, surveillance and data collection will occur throughout the study in all clinics throughout the four districts. All obstetric events occurring in any of the participating health facilities and districts during the 18 months implementation period will be included in the analysis, controlling for the cluster design. Our main outcome measures will be the change in perinatal mortality and in the proportion of institution-based deliveries.DiscussionA unique feature of this protocol is that we are not proposing an individual intervention, but rather a package of interventions, which is designed to address the complexities and realities of maternal and perinatal mortality in developing countries. To date, many other countries, has focused its efforts to decrease maternal mortality indirectly by improving infrastructure and data collection systems rather than on implementing specific interventions to directly improve outcomes.Trial registrationClinicalTrial.gov,http://NCT01653626.

Emergency obstetric simulation training: How do we know where we are going, if we don't know where we have been?

“…Current evidence emphasises the impact of training on confidence, knowledge and skills of participants with minimal evidence for the clinical impact of training on maternal or perinatal morbidity or mortality. There are trials currently underway to look specifically at clinical outcomes from simulation‐based training . Further work is required in this area.…”

An integrated approach to improve maternal and perinatal outcomes in rural Guatemala: A stepped‐wedge cluster randomized trial

“…After promising results from a pilot project that built interest among local stakeholders, a prospective trial aim to implement and evaluate the impact of an intervention package at scale, was launched across the two rural districts of Huehuetenango and Alta Verapaz 17 . Given the nature of the intervention package, health centers and the municipalities were chosen as clusters and serve as the unit of delivery of the intervention and randomization to assess the impact of the intervention on the outcomes of all births occurring at the health center level.…”

“…Data were extracted from health center records by using an adapted 30‐question tool previously used in a pilot phase of the study 17 . Field workers were trained in data collection procedures including data protection and privacy.…”

In search of Pan-American indigenous health and harmony

“…Research on a remote Peruvian region comprised of mostly indigenous peoples found an association between biomass fuel use and increased risk of hypertension and higher blood pressure [9]. A current Guatemalan report seeks insight on indigenous perinatal mortality after construction of 68 centers for labor and delivery [39].…”