Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach
NCT06273007 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2024-02-22
Summary
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.
Conditions
- Stillbirth
- Obstetric Complication
- Maternal Death
- Perinatal Death
- Perinatal Morbidity
Interventions
- OTHER
-
PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings
We will implement PartoMa interventions: seminars, LDHF training, and supportive supervision
Sponsors & Collaborators
-
University of Copenhagen
collaborator OTHER -
Leiden University Medical Center
collaborator OTHER -
Laerdal Foundation
collaborator OTHER -
Haramaya Unversity
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-01
- Primary Completion
- 2025-12-31
- Completion
- 2027-12-31
Countries
- Ethiopia
Study Locations
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