Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06273007
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-15
Brief Title:
Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach
Sponsor:
Haramaya Unversity
Organization:
Haramaya Unversity
Study Overview
Official Title:
Introducing PartoMa Approach to Ethiopia for Improving Intrapartum Care and Maternal Survival The Case of the Ethiopian Obstetric Surveillance System PartoMa-Ethiopia
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PartoMa-Eth
Brief 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 atafter 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 5000
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 atafter 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 5000
Detailed Description:
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
Phase II
Co-creation of PartoMa guidelines to Ethiopia month 3-6 Input from the baseline assessment local birth attendants and stakeholders will be used to adapt the PartoMa guidelines from Tanzania to the hospital context Together with local birth attendants doctors and midwifes evidence from international adapted to locally achievable guidelines We will integrate PartoMa Ethiopia with MOYO device for monitoring FHR for improving the still births and supporting the decision-making process The guideline will be peer reviewed by the international PartoMa team national consultant obstetricians and senior midwives
Phase III
Introduction of PartoMa Ethiopia in Haramaya Hospital month 7-18 After completing co-creation of PartoMa Ethiopia guidelines PartoMa seminars and FHR monitoring will be introduced in Haramaya Hospital Once PartoMa Ethiopia seminar is introduced monitoring and evaluation of the process will be conducted Using the Kirkpatricks model-which is ideal for evaluating impact of training at different level-will be used for evaluation purpose Comprehensive data collection including non-participatory observation of labor ward and interview of birth attendants and the women will be used for data collection objective II and III PartoMa seminars will be complemented with real case scenarios obtained from Ethiopian Obstetric Surveillance System EthOSS database Different level of training outcomes will be evaluated following the different level of Following the Kirkpatricks model we will evaluate the training outcomes at level one reaction level two learning level three behavior and level four results
Phase IV
Post implementation evaluation and sustainability Month 19-24 Following implementation of PartoMa Ethiopia packages with MOYO FHR monitoring for 12 months final data collection will be done following similar approach the same measuring tools data collection technique and outcomes
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
Phase II
Co-creation of PartoMa guidelines to Ethiopia month 3-6 Input from the baseline assessment local birth attendants and stakeholders will be used to adapt the PartoMa guidelines from Tanzania to the hospital context Together with local birth attendants doctors and midwifes evidence from international adapted to locally achievable guidelines We will integrate PartoMa Ethiopia with MOYO device for monitoring FHR for improving the still births and supporting the decision-making process The guideline will be peer reviewed by the international PartoMa team national consultant obstetricians and senior midwives
Phase III
Introduction of PartoMa Ethiopia in Haramaya Hospital month 7-18 After completing co-creation of PartoMa Ethiopia guidelines PartoMa seminars and FHR monitoring will be introduced in Haramaya Hospital Once PartoMa Ethiopia seminar is introduced monitoring and evaluation of the process will be conducted Using the Kirkpatricks model-which is ideal for evaluating impact of training at different level-will be used for evaluation purpose Comprehensive data collection including non-participatory observation of labor ward and interview of birth attendants and the women will be used for data collection objective II and III PartoMa seminars will be complemented with real case scenarios obtained from Ethiopian Obstetric Surveillance System EthOSS database Different level of training outcomes will be evaluated following the different level of Following the Kirkpatricks model we will evaluate the training outcomes at level one reaction level two learning level three behavior and level four results
Phase IV
Post implementation evaluation and sustainability Month 19-24 Following implementation of PartoMa Ethiopia packages with MOYO FHR monitoring for 12 months final data collection will be done following similar approach the same measuring tools data collection technique and outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None