ePartogram Effectiveness Study: A Mixed Methods Quasi-experimental Study in Kisumu and Meru, Kenya.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Jhpiego
- 入组人数
- 113
- 试验地点
- 12
- 主要终点
- Percent of partographs showing fetal/newborn with a suboptimal fetal/newborn outcome
研究概览
简要总结
Quasi-experimental study to evaluate whether clinical care offered to clients was more appropriate and in line with WHO recommendations for care in normally progressing labor and in labor with complications, among providers using the novel intervention, ePartogram (an electronic version of the WHO paper partograph) vs. providers who offered care using the standard paper partograph, and whether fetal/newborn outcomes were improved among cases where partograph was used.
详细描述
The ePartogram is an electronic version of the WHO Partograph and is developed by Jhpiego. Seventy-eight clinical rules, programmed into the ePartogram, are based on global guidelines in the WHO manual "Managing complications in pregnancy and childbirth: a guide for midwives and doctors" and the expert opinion of Jhpiego physicians and nurse-midwives. The rules underwent a validation process by 65 expert skilled birth attendants (SBAs) (working in maternity wards of health facilities) from a variety of geographic and clinical settings affiliated with Jhpiego. In the ePartogram application ("app") that is put on an Android tablet computer, the clinical rules trigger "reminders" to SBAs to take a routine clinical measurement, such as fetal heart rate (every 30 minutes) or maternal temperature (every 2 hours). The rules also trigger "low-level" alarms indicating a measurement that falls in the abnormal range that could be cause for concern (i.e. meconium-stained liquor), and "high-level" alarms that could indicate need for immediate action (i.e. maternal systolic blood pressure ≥160 mm Hg).
Litwin et al. reported on the feasibility and acceptability of use of an electronic partogram in Zanzibar and concluded that health workers felt the ePartogram improved timeliness of care and supported decision making. Health workers quickly became competent and confident in using the tablet device and ePartogram application. This study in Kenya has an objective to evaluate whether providers' use of the ePartogram improves labor outcomes and labor management in health facilities. The study design is a quasi-experimental design evaluation comparing data collected at 6 intervention sites and 6 comparison sites with similar facility characteristics and in two regions of Kenya.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Facilities:
- •In Kisumu or Meru
- •BEmONC or CEmONC sites
- •At least one SBA on duty in labor ward 24 hours per day
- •Facility in-charge or in-charge of L&D ward available physically or remotely 24 hours per day
- •Use WHO modified paper partograph
- •Adequate supply of paper partographs and maternity registers
- •Availability of reliable transportation for referrals (e.g. functional ambulance) 24 hours per day
- •Providers meeting the WHO definition of Skilled Birth Attendant (SBA) clinical provider working in care for laboring women who will be working at the facility during the study.
- •Providers completing the three-day labor management training comprised of training on partograph use and management of normal labors and labor complications, according to WHO and Kenya MOH guidelines
- •Intervention sites only: Providers passing the ePartogram post-training test will be asked to use the ePartogram during clinical care.
排除标准
- •Facilities:
- •Facility not registered with MOH
- •No SBA on duty in labor ward at any time during a 24 hour period
- •No in-charge available at any time during a 24 hour period
- •Dispensary health facilities that do not practice BEmONC
- •Providers not meeting the WHO definition of SBA
- •Providers not completing the labor management training or (intervention sites only) not passing the ePartogram post-training test
结局指标
主要结局
Percent of partographs showing fetal/newborn with a suboptimal fetal/newborn outcome
时间窗: All partographs within the 6 month intervention period; the partograph is started in the active phase of labor - at 4 cm dilatation - and may last up to 12 hours
Percent of partographs with a suboptimal fetal/newborn outcome (defined by presence of fresh stillbirth, newborn Apgar score of 5 or below at 1 minute, or Apgar score of 7 or below at 5 minutes or newborn resuscitation needed -- as recorded on the partograph by the health provider)
次要结局
- Action recorded on partograph to maintain normal labor, among all partographs or partograms(Six-month intervention period)
- Percent of partographs with a suboptimal maternal outcome(All partographs within the 6 month intervention period; the partograph is started in the active phase of labor - at 4 cm dilatation - and may last up to 12 hours)
- Action recorded by the provider to address any sign of non-normalcy in labor, among all partographs or partograms(Six-month intervention period)
- Fresh stillbirth and neonatal death <24 hours out of all births, according to aggregate monthly routine facility data(Six-month intervention period and six-month pre-intervention period)