Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan.
BMC Pregnancy Childbirth. 2010 Dec 14;10:82. doi: 10.1186/1471-2393-10-82.
Maternal and newborn mortality rates remain unacceptably high, especially where the majority of births occur in home settings or in facilities with inadequate resources. The introduction of emergency obstetric and newborn care services has been proposed by several organizations in order to improve pregnancy outcomes. However, the effectiveness of emergency obstetric and neonatal care services has never been proven. Also unproven is the effectiveness of community mobilization and community birth attendant training to improve pregnancy outcomes.
METHODS/DESIGN: We have developed a cluster-randomized controlled trial to evaluate the impact of a comprehensive intervention of community mobilization, birth attendant training and improvement of quality of care in health facilities on perinatal mortality in low and middle-income countries where the majority of births take place in homes or first level care facilities. This trial will take place in 106 clusters (300-500 deliveries per year each) across 7 sites of the Global Network for Women's and Children's Health Research in Argentina, Guatemala, India, Kenya, Pakistan and Zambia. The trial intervention has three key elements, community mobilization, home-based life saving skills for communities and birth attendants, and training of providers at obstetric facilities to improve quality of care. The primary outcome of the trial is perinatal mortality. Secondary outcomes include rates of stillbirth, 7-day neonatal mortality, maternal death or severe morbidity (including obstetric fistula, eclampsia and obstetrical sepsis) and 28-day neonatal mortality.
In this trial, we are evaluating a combination of interventions including community mobilization and facility training in an attempt to improve pregnancy outcomes. If successful, the results of this trial will provide important information for policy makers and clinicians as they attempt to improve delivery services for pregnant women and newborns in low-income countries.
ClinicalTrials.gov NCT01073488.
孕产妇和新生儿死亡率仍然高得令人无法接受，尤其是在大多数分娩发生在家庭环境或资源不足的设施中的情况下。为了改善妊娠结局，一些组织提出了紧急产科和新生儿护理服务。然而，紧急产科和新生儿护理服务的有效性从未得到证实。同样未经证实的是社区动员和社区助产士培训以改善妊娠结局的有效性。
方法/设计：我们开发了一项整群随机对照试验，以评估社区动员、助产士培训和改善卫生设施护理质量的综合干预措施对大多数分娩发生在家庭或一级保健设施中的中低收入国家围产期死亡率的影响。这项试验将在阿根廷、危地马拉、印度、肯尼亚、巴基斯坦和赞比亚的全球妇女和儿童健康网络的 7 个地点的 106 个群组（每年每个群组 300-500 次分娩）中进行。试验干预有三个关键要素，即社区动员、社区和助产士的家庭救生技能，以及提高产科设施提供者护理质量的培训。试验的主要结局是围产期死亡率。次要结局包括死产率、7 天新生儿死亡率、产妇死亡或严重发病率（包括产科瘘、子痫和产科败血症）和 28 天新生儿死亡率。
在这项试验中，我们正在评估包括社区动员和设施培训在内的一系列干预措施，以试图改善妊娠结局。如果成功，该试验的结果将为决策者和临床医生提供重要信息，因为他们试图改善低收入国家孕妇和新生儿的分娩服务。
ClinicalTrials.gov NCT01073488。
