Stillbirth Clinical Trial
— PartoMa-EthOfficial title:
Introducing PartoMa Approach to Ethiopia for Improving Intrapartum Care and Maternal Survival: The Case of the Ethiopian Obstetric Surveillance System (PartoMa-Ethiopia)
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 1. Locally agreed and achievable intrapartum guidelines 2. Low dose high frequency trainings (LDHF) 3. 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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - NA |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Haramaya Hospital | Harar | Oromia |
Ethiopia | Hiwot Fana University Hospital | Harar |
Lead Sponsor | Collaborator |
---|---|
Haramaya Unversity | Laerdal Foundation, Leiden University Medical Center, University of Copenhagen |
Ethiopia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | stillbirth | Still birth= fetal death after 28 wk of gestation or weighing >/= 1000g (both with /without positive fetal heart rate on admission). | A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention | |
Primary | Birth Asphyxia | newborns with a 5minute APGAR score <7 | A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention | |
Secondary | Maternal death | Deaths of women at the study site while pregnant or within 42 days postpartum, from any cause related to or aggravated by pregnancy or its management | A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention | |
Secondary | Cesarean sections and vacuum extractions | All woman who gave birth through Cesarian Sections and Vacuum extractions | A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention | |
Secondary | Process indicators of quality of intrapartum care | This includes partograph utilization, timely monitoring of ( fetal heart rate, labour progress, and maternal vital signs), and oxytocin use for labour augmentation. Management is compared to pre-selected audit criteria.Management will be compared to pre-selected audit criteria | A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention | |
Secondary | Birth attendant's perception of their work condition in the labour and delivery rooms | Participant observations and in-depth interviews | A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention | |
Secondary | The women's experience of care received during delivery. | By focus group discussion | A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention |
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