Evaluating the Effects of Clinical Decision Making Support Systems on Maternal and Neonatal Mortality and Morbidity in Ghana: a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65,831
- 试验地点
- 2
- 主要终点
- Number of neonatal deaths
研究概览
简要总结
Introduction Maternal and neonatal mortality continue to be to be prominent public health issues in sub Saharan Africa including Ghana, with slow progress made towards attainment of Millennium Development Goals (MDG) 4 & 5. Studies have identified poor quality of maternal and child healthcare as a major challenge to the prevention of neonatal and maternal deaths. Effective interventions are required to make significant inroads in these areas.
Objective To evaluate the effect of a SMS text messaging intervention to support clinical decision making by frontline health care professionals on neonatal and maternal mortality.
Methods We propose to conduct a randomized controlled trial in the Eastern region of Ghana, involving 8 intervention and 8 control districts. The intervention consists of text messaging of standard protocols for maternal and neonatal care to front line health care providers in the region. A total of 17,040 pregnant women who are receiving care (including antenatal, delivery and post-natal) at any of the hospitals in the selected districts in the region will be monitored through monthly aggregate data on outcome measures such as neonatal and maternal deaths from eclampsia, postpartum haemorrhage, puerperal sepsis, birth asphyxia, low birth weight and neonatal sepsis. Cord sepsis will also be included as neonatal sepsis for this study. Also, a quality of care assessment in four sampled districts to measure adherence to the safe motherhood protocol will be conducted. Stata software package.55 and MLwiN software version 2.2456 will be employed in data analysis. Descriptive analysis will be carried out to explore baseline characteristics of study groups while logistic regression will be applied to evaluate the effect of the intervention. A two-tailed statistical significant level of 0.05 will be used.
Expected outcome We hypothesize that the intervention will improve both maternal and neonatal service delivery and health outcomes in the intervention areas.
详细描述
Rationale of Study Based on the preponderance of evidence provided so far, Ghana is not on track for MDG 4 & 5.31 Despite increased antenatal care attendance in the health facilities,and the number of pregnancy delivered by skilled health care workers,neonatal and maternal mortality have not seen the needed decline.
Maternal deaths and neonatal deaths are caused by a complex interaction of economic, financial, social, cultural and clinical factors. Clinical factors are related to access to and quality of antenatal care, skilled attendance at delivery and emergency obstetric care. With over 90% of pregnant women receiving antenatal care from a health professional,it is believed that if adequate care is offered to these women, birth outcomes will be improved. Gaps identified in the quality of care given to pregnant women include poor quality of clinical decision guiding provider decisions on management choices.
Considering this we propose an evidence-based intervention facilitating easy access to maternal and neonatal guidelines for routine and emergency obstetric and antenatal/neonatal care for frontline providers, in public facilities. For the purpose of this intervention, we have chosen as a reference guideline the national Safe Motherhood protocol,an elaborate tool, that provides detailed state-of-the-art guidelines for maternal and newborn care, starting from prenatal care, through antenatal, delivery, postpartum, and newborn care. We chose text messaging based on the Unstructured Supplementary Service Data (USSD) system as a low-cost, easily-accessible and instant way of requesting needed information in standard and emergency situations by the health care provider to enhance clinical decision making.
Objectives Primary objective
- To assess the quantitative effect of USSD-based text messaging of standard protocols for maternal and neonatal care on the incidence of neonatal mortality Secondary objectives
- To assess the quantitative effect of USSD-based text messaging of standard protocols for maternal and neonatal care on the incidence of maternal mortality
- To assess the quantitative effect of USSD-based text messaging of standard protocols for maternal and neonatal care on the incidence of neonatal morbidity
- To assess the quantitative effect of USSD-based text messaging of standard protocols for maternal and neonatal care on the incidence of maternal morbidity
- To assess adherence of health care providers to clinical guidelines for maternal antenatal care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •District location in the Eastern region of Ghana.
- •The districts should have an expected deliveries of ≥ 1,100 / year
- •The District Health Management Team and the District Hospital Management Team must agree to participate in the study.
排除标准
- •District location outside the Eastern region.
- •The districts expected deliveries of <1,100 / year
- •The District Health Management Team and the District Hospital Management Team disagreeing to participate in the study.
研究组 & 干预措施
Intervention districts
Access to protocols for management of obstetric and neonatal emergencies via text messaging on request in Intervention districts. Maternal and Neonatal emergency protocols
干预措施: Maternal and neonatal emergency protocols (Other)
Control districts
No access to protocols for management of obstetric and neonatal emergencies via text messaging in control district
结局指标
主要结局
Number of neonatal deaths
时间窗: 18 months
Total number of neonatal deaths among total number of deliveries over an 18 month period
次要结局
- Number of maternal deaths(18 months)
- Number of cases of cord sepsis(18 months)
- Number of cases of eclampsia(18 months)
- Number of cases of prolonged labour(18 months)
- Number of cases of puerperal sepsis(18 months)
- Number of cases of postpartum haemorrhage(18 months)
- Number of cases of birth asphyxia among deliveries(18 months)
- Number of cases of low birth weight deliveries(18 months)
研究者
Hannah Brown Amoakoh
Clinical trials coordinator
Julius Global Health