Introducing PartoMa Approach to Ethiopia for Improving Intrapartum Care and Maternal Survival: The Case of the Ethiopian Obstetric Surveillance System (PartoMa-Ethiopia)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Birth Asphyxia
研究概览
简要总结
Overall Objective
To introduce PartoMa approach (locally agreed and achievable intrapartum guidelines and a continual in-house training program) to Ethiopian context through continuous fetal heart rate (FHR) monitoring using MOYO device and co-creation of context specific intrapartum care guideline for improving decision making in intrapartum care in Eastern Ethiopia.
Interventions
- Locally agreed and achievable intrapartum guidelines
- Low dose high frequency trainings (LDHF)
- Partograph Overall Design
A quasi-experimental pre-post study (PartoMa study)
Setting
Department of Obstetrics and Gynaecology Haramaya Hospital and Hiwot Fana University Hospital, Ethiopia.
Population
Laboring women delivering at the study site from February 2023 to March 2025 and their offspring, as well as health providers. Women and their offspring will be enrolled at/after onset of labour and followed until discharge.
Endpoints
The primary endpoint is perinatal mortality. For further description and secondary outcomes, please see below.
Study Time
Data collection from June 2023 to May 2025.
Specific Objectives i. To assess FHR monitoring practice and use of obstetric guideline for decision making in Hiwot Fana University Hospital ii. To improve feto-maternal outcome through applying PartoMa approach in Hiwot Fana University Hospital.
iii. To determine the feasibility, acceptability and sustainability of low-dose high frequency trainings and PartoMa seminars in Hiwot Fana University Hospital.
iv. To document changes in pregnancy outcomes after the introduction of PartoMa approaches-seminars, low dose high frequency trainings, continuous FHR monitoring and tailored interventions-in Hiwot Fana University Hospital.
Setting
PartoMa Ethiopia will be implemented at Haramaya General Hospital and Hiwot Fana Comprehensive Specialized University Hospital, which are both busy maternity units in Eastern Ethiopia. Both are government hospitals with an annual delivery number of around 5,000.
详细描述
METHODS
The embedded study consists of four phases of activities:
I. Baseline assessment, II. Co-creation context specific intrapartum care guideline, III. Implementation of PartoMa seminars, and IV. Post intervention evaluation.
Phase I:
Baseline Assessment of Current Practice (the first three month) Using a mixed method design, detail baseline quality of care assessment will be conducted which include FHR monitoring practice, criterion-based audit of intrapartum management in cases of still births, compliance with obstetric guidelines and basic maternal and child health indicators, through interview of staff, review of records, and observations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women in labour delivering at the study site and their outcome, July - September 2023 and July -September 2025
- •All birth attendant at the study site in obstetrics and gynecology departments during the baseline and intervention period, July - September 2023 and July -September 2025
排除标准
- 未提供
研究组 & 干预措施
woman in labor
All women in labour during the study period (3 months baseline and the 3rd-6th month of the intervention) will be included for this pre- vs post-study of the PartoMa intervention.
The following subgroups will be studied in-depth:
- All stillbirths
- 5th Minute APGAR score <7
- All maternal deaths
- All women with severe obstetric complication (postpartum hemorrhage, hypertensive disorders of pregnancy, uterine rupture, obstructed labor)
干预措施: PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings (Other)
Birth attendants
All health care providers (physicians and midwives) working at the department of obstetrics during the study period will be invited to participate in knowledge tests of obstetric care and qualitative study. participant observations as well as in-depth interviews regarding quality of intrapartum care. This is a part of evaluating the use and effectiveness of the PartoMa intervention.
干预措施: PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings (Other)
结局指标
主要结局
Birth Asphyxia
时间窗: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
newborns with a 5minute APGAR score \<7
stillbirth
时间窗: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
Still birth= fetal death after 28 wk of gestation or weighing \>/= 1000g (both with /without positive fetal heart rate on admission).
次要结局
- Birth attendant's perception of their work condition in the labour and delivery rooms(A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention)
- Cesarean sections and vacuum extractions(A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention)
- The women's experience of care received during delivery.(A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention)
- Maternal death(A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention)
- Process indicators of quality of intrapartum care(A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention)
研究者
ABERA KENAY TURA
Dr.
Haramaya Unversity