Enabling Best Post Possible Childbirth Care in Tanzania.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65,181
- 试验地点
- 1
- 主要终点
- Stillbirths.
研究概览
简要总结
Introduction
Childbirth care remains suboptimal in many low-resource settings, causing unacceptable maternal and perinatal mortality and morbidity. Realistic, context-tailored clinical support is called for to assist birth attendants in providing best possible evidence-based and respectful care. The PartoMa pilot study from Zanzibar suggested that co-created clinical practice guidelines and low-dose, high-frequency training were associated with care improvements and perinatal survival. In the present study we will modify, implement and evaluate this intervention in five urban, high-volume maternity units in Tanzania.
Methods and Analysis
The study design is based on a theory of change, and includes three main steps: I. A mixed-methods situational analysis will explore factors affecting care. Step II. Based on step I., the PartoMa guidelines and training will be contextually modified through discussions with birth attendants and postpartum women. III. The modified intervention will be implemented through a stepped-wedge cluster trial, with embedded qualitative and economic analyses. Women in active labour and their offspring will be followed until discharge to assess intra-hospital stillbirths, intra-facility neonatal deaths and caesarean sections without medical indications, and the incremental cost-effectiveness ratio will be measured. Central intermediate outputs include health providers' knowledge, barriers and facilitators to intervention use, and clinical performance.
详细描述
Background
Globally, 300,000 women and 5 million children die each year in relation to childbirth. Most would have survived had they been given proper care.
Multiple clinical guidelines have been developed to improve maternity care in low-resource settings. However, they are often incompatible with the contextual realities. Maternity units in low-resource settings often deal with limited capacity, high turnover of staff and an unworkable ratio of labouring women per birth attendant. This often makes it impossible to adhere to international clinical guidelines and calls for research on effective development, implementation and upscaling of achievable clinical guidelines for such settings.
The PartoMa project's focus on generating evidence-based and respectful childbirth care is a key priority to reach the Sustainable Development Goals - particularly on birth-related survival and gender equality, but also in regards to societal development and poverty reduction. Also, the PartoMa project might serve as an example of context-tailored development and implementation of guidelines for other areas of health care.
The PartoMa Dar es Salaam intervention study will be carried out in the five highest volume maternity units in the fast growing urban center of Dar es Salaam, Tanzania: Amana Hospital, Temeke Hospital, Mwanyamala Hospital, Sinza Health Centre, and Mbagala R. Health Centre. A total of 50,000 births occur in these five facilities each year, providing a typical example of overburdened urban maternity units in low-income countries. In these contexts, quality of care is negatively impacted by lack of staff, persistent increases in births due to urbanization, and increased demand for facility birth. These facilities primarily serve women of lower socioeconomic background. Each birth attendant typically takes care of at least 3-6 labouring women simultaneously.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All deliveries recorded at the five hospital sites during the entire study period.
- •All women in labour delivering at the five study sites.
- •All health care providers in delivery wards at the five study sites during the baseline and intervention period.
- •For the different substudies, sub-groups are selected (please see the secondary outcomes for a description)
- •(Please notice that all women and newborn children will be included in the the study, irrespectively of their health status)
- •Exlusion Criteria:
- •There are no
排除标准
- 未提供
研究组 & 干预措施
Women in labour
All women in labour during the study period will be included for this pre- vs. post-study of the PartoMa intervention.
The following subgroups will be studied in-depth:
- All stillbirths
- All children born with low Apgar score
干预措施: The PartoMa guidelines and training (Behavioral)
结局指标
主要结局
Stillbirths.
时间窗: 2 years
Intrahospital stillbirths (\>=1000g, recorded positive FHR on admission) per 1000 total births. Data collection method: Prospective case file reviews. Data on stillbirths will be prospectively collected from baseline and until 12 months after the last facility receives the intervention, including stillbirths weighing at least 1000g with positive foetal heart rate on admission. The data will be will be gathered daily from hospital files, i.e. hospital registers and medical records, and cross-checked with the facilities' routinely kept birth registers.
次要结局
- Costs and cost-effectiveness of intervention.(2 years.)
- Vacuum-assisted deliveries.(2 years.)
- Cesarean deliveries.(2 years.)
- Newborn with low Apgar score.(2 years.)
研究者
Dan Meyrowitsch
Epidemiologist, PhD, Associate Professor, Head of research,
University of Copenhagen