Epidemiological Research Center in Sexual and Reproductive Health (CIESAR), Guatemala City, Guatemala.
BMC Pregnancy Childbirth. 2013 Mar 21;13:73. doi: 10.1186/1471-2393-13-73.
Maternal 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/DESIGN: A 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.
A 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.
ClinicalTrial.gov,http://NCT01653626.
孕产妇和围产儿死亡率仍然是较不发达国家卫生议程上的一个高度优先问题。尽管在过去十年中取得了量化孕产妇死亡率的进展，但很少有干预措施被实施，目的是直接衡量对孕产妇或围产儿死亡的影响。在较不发达国家实施的降低死亡率的干预措施的成功受到了质疑，因为这些干预措施倾向于保持临床观点，侧重于纯粹的医疗保健，而不考虑考虑孕产妇和围产儿死亡的文化和社会方面的基于社区的方法。我们的创新方法同时利用临床和社区观点；此外，我们的研究将报告这些组成部分中的每一个在降低围产儿死亡率和增加基于机构的分娩方面可能具有的权重。
方法/设计：将在危地马拉孕产妇死亡率最高的四个农村土著地区的诊所进行匹配对聚类随机试验。个体诊所将作为随机分组的单位，15 对对照和干预诊所组成最终样本。将在土著、农村和贫困人群中实施三项干预措施：紧急产科和围产儿护理模拟培训计划、增加专业助产士参与加强传统助产士和正规卫生保健系统之间联系，以及促进基于机构的分娩的社会营销运动。对照诊所不计划进行外部干预，但在整个研究期间，将在所有诊所加强监测、监测和数据收集。在参与卫生机构和地区的 18 个月实施期间发生的所有产科事件都将包括在分析中，控制聚类设计。我们的主要结局指标将是围产儿死亡率的变化和基于机构的分娩比例的变化。
本方案的一个独特特点是，我们不是提出一个单一的干预措施，而是一个干预措施包，旨在解决发展中国家孕产妇和围产儿死亡率的复杂性和现实。迄今为止，许多其他国家将其努力重点放在间接通过改善基础设施和数据收集系统来降低孕产妇死亡率，而不是实施具体干预措施来直接改善结果。
ClinicalTrial.gov，http://NCT01653626。
