Prevention of Neonatal and Maternal Infection During Labor and Delivery in Rural Healthcare Sites in Zambia - Intervention Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 5
- 主要终点
- Infection control practices assessed by Infection Control Assessment Tool (ICAT) score
研究概览
简要总结
This is the intervention phase of a study to investigate the impact of low-cost bundled interventions on improving the infection control practices in the labor and delivery units in rural healthcare settings in Zambia. A baseline observational phase of the health care providers' infection control procedures was done. In this intervention phase, low-cost bundle of interventions, including health care provider education, behavior feedback, visual and Short Message Service (SMS)/text message reminders, and provision of alcoholic hand rubs, will be implemented at 5 study sites. 12 weeks after the initiation of interventions, endline data will be collected. The data from endline after interventions will be compared with baseline data from observational phase to detect changes in infection control practices at each study site after the interventions.
详细描述
The total duration of the intervention phase is estimated to be 4 months. During this time, the investigators will collaborate with the healthcare workers (HCWs) at each study site and the district pharmacist.
The study team will visit each site separately and administer the training modules on-site during the first month of the research until all of the modules have been completed for all of the Labor and Delivery (L&D) staff, which usually consist of about 2-3 people. A quiz will be administered before and after the training session to assess change in knowledge after the training.
SMS reminders will be sent every weekday to promote best infection control practices in the L&D. Posters will also be posted for visual reminders of best practices around the health center.
After the initial training, each health centers will be visited twice a month by a study team member to assess alcohol rubs (AHR) stock, gather feedback and comments, and evaluate postpartum maternal and neonatal infectious complications and hospital outcomes. Infection and outcome data will be shared with each site monthly. About 2 months after initial training, a refresher education and training course will be held at each study site. A quiz will be administered before and after the refresher course to assess knowledge.
The investigators will collaborate with the district pharmacy for production and distribution of AHR. The pharmacists will receive training on how to combine and mix the hand rub components per WHO guidelines, and test batches will be made prior to distribution to study sites to ensure familiarity of the pharmacy staff with its production. Quality control with an alcoholmeter will be performed with the alcohol ingredient and with the finished product, as per World Health Organization (WHO) recommendation. Afterwards, the head pharmacist will be consulted biweekly by study team member to document AHR production, budget, distribution, and any other issues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for observation:
- •Women of age > 15 in early first stage of labor (cervical dilation ≤ 6cm) at the study sites during the study period
- •If woman is 15 to 17 must have a guardian present
- •Planned vaginal delivery
- •Any healthcare workers providing direct patient care to women delivering at the study sites during study period
排除标准
- •for observation:
- •Any eligible woman who presents past the early first stage of labor (cervical dilation > 6cm)
- •Woman under 18 years old without a guardian present
- •Inclusion criteria for logbook review:
- •Women who delivered their baby at the study sites during the study period
- •Newborns who were born at the study sites during the study period
研究组 & 干预措施
Preventing L&D Infections
Low-cost bundled L&D infection prevention interventions will be implemented, including education, visual reminders, feedback, and alcoholic hand rub supply. Infection control practices and child delivery outcomes will be assessed after implementation of these interventions.
干预措施: Bundled L&D Infection Prevention Interventions (Other)
结局指标
主要结局
Infection control practices assessed by Infection Control Assessment Tool (ICAT) score
时间窗: 12 weeks
A survey including 98 questions detailing infection control practices in the L\&D. It includes questions on facility, Infection Prevention and Control (IPC) program, general IPC, hand hygiene, L\&D practices, and postpartum care practices. The scores from each question on the survey will be summed for the ICAT score for each health center. Maximum score is 140 points and minimum score is 0 points, with higher score indicating better infection control practices. Of the 98 questions, 34 questions are duplicated in an observation tool in order to corroborate the accuracy of survey information by direct observation. The observation tool includes topics on supplies in the L\&D and healthcare worker behaviors during childbirth. ICAT was developed by the Rational Pharmaceutical Management plus Infection Control Project team in 2009.
次要结局
- Rates of maternal hospital outcome categories from medical records(12 weeks)
- Rates of neonatal hospital outcomes from medical records(12 weeks)
- HCW attitudes towards infection control interventions from an anonymous survey(12 weeks)
- Number of mothers with postpartum maternal infection from medical records(12 weeks)
- Number of newborns with postpartum neonatal infection from medical records(12 weeks)