StillbirthPartoMa-EthNCT06273007
Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach
A study testing PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings in people with Stillbirth and Obstetric Complication, run by Haramaya Unversity at 2 sites in Ethiopia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Stillbirth, Obstetric Complication, Maternal Death
- What is being tested?
- PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesEthiopia
- Study dates
- 1 Jun 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- NA
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia2 sites, 2 recruiting
- Recruiting
Haramaya Hospital
Harar, Oromiya
Roba Ararsa, MD
- Not yet recruiting
Hiwot Fana University Hospital
Harar
Redwan Ahmed, MD
About this study
Official 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.
Read more
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.
Read the detailed description
METHODS
The embedded study consists of four phases of activities:
- 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 inter(national) 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 Kirkpatrick's 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 Kirkpatrick's 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.
- Being tested
- PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings
- Keywords
- Obstetrics, perinatal, maternal, Intrapartum, Quality, PartoMa, LDHF
- Medical subject headings
- Stillbirth, Maternal Death, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainingsOther
Also called LDHF trainings, Partograph
We will implement PartoMa interventions: seminars, LDHF training, and supportive supervision
| Study group | Role | What they receive |
|---|---|---|
| woman in labor | Experimental | 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:
1. All stillbirths
2. 5th Minute APGAR score <7
3. All maternal deaths
4. All women with severe obstetric complication (postpartum hemorrhage, hypertensive disorders of pregnancy, uterine rupture, obstructed labor) Receives: Other: PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings |
| Birth attendants | Experimental | 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. Receives: Other: PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings |
What is being measured
The primary outcome is the main question the study is designed to answer.
stillbirth
Still birth= fetal death after 28 wk of gestation or weighing >/= 1000g (both with /without positive fetal heart rate on admission).
Measured: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
Birth Asphyxia
newborns with a 5minute APGAR score <7
Measured: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
Secondary outcomes (5)
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
Measured: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
Cesarean sections and vacuum extractions
All woman who gave birth through Cesarian Sections and Vacuum extractions
Measured: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
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
Measured: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
Birth attendant's perception of their work condition in the labour and delivery rooms
Participant observations and in-depth interviews
Measured: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
The women's experience of care received during delivery.
By focus group discussion
Measured: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Jun 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StillbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haramaya Unversity
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Leiden University Medical Center, Laerdal Foundation
- Responsible party
- Principal investigator, ABERA KENAY TURA, Haramaya Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273007
- Sponsor's protocol ID
- EFP_2023_02_19
- Acronym
- PartoMa-Eth
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bekele H, van den Akker T, Maaloe N, Girma S, Mohammed RA, Wale H, Ararso R, Jemal E, van Roosmalen J, Housseine N, Tura AK. Coadaptation and implementation of intrapartum clinical guidelines to save lives during childbirth: Protocol for an adapted PartoMa intervention in Eastern Ethiopia. BMC Health Serv Res. 2026 Feb 20;26(1):407. doi: 10.1186/s12913-026-14228-4.
PubMed 41715069
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing PartoMa Approach to Ethiopia for Improving Intrapartum Care and Maternal Survival: The Case of the Ethiopian Obstetric Surveillance System (PartoMa-Ethiopia)
- ClinicalTrials.gov ID
- NCT06273007
- Acronym / sponsor ID
- PartoMa-Eth / EFP_2023_02_19
- Keywords
- Obstetrics, perinatal, maternal, Intrapartum, Quality, PartoMa, LDHF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Haramaya UnversityUniversity, hospital or other
- Collaborators
- University of Copenhagen, Leiden University Medical Center, Laerdal Foundation
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
METHODS
The embedded study consists of four phases of activities:
- 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 inter(national) 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 Kirkpatrick's 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 Kirkpatrick's 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| woman in labor | Experimental | Other: PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainingsAll 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: 1. All stillbirths 2. 5th Minute APGAR score <7 3. All maternal deaths 4. All women with severe obstetric complication (postpartum hemorrhage, hypertensive disorders of pregnancy, uterine rupture, obstructed labor) |
| Birth attendants | Experimental | Other: PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainingsAll 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainingsAlso: LDHF trainings, PartographWe will implement PartoMa interventions: seminars, LDHF training, and supportive supervision | Other | Birth attendants, woman in labor |
Primary outcome
stillbirth
Time frame: 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).
Birth Asphyxia
Time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
newborns with a 5minute APGAR score <7
5 secondary outcomes
Maternal death
Time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
Cesarean sections and vacuum extractions
Time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
Process indicators of quality of intrapartum care
Time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
Birth attendant's perception of their work condition in the labour and delivery rooms
Time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
The women's experience of care received during delivery.
Time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Derived from this study: PubMed 41715069Bekele H, van den Akker T, Maaloe N, Girma S, Mohammed RA, Wale H, Ararso R, Jemal E, van Roosmalen J, Housseine N, Tura AK. Coadaptation and implementation of intrapartum clinical guidelines to save lives during childbirth: Protocol for an adapted PartoMa intervention in Eastern Ethiopia. BMC Health Serv Res. 2026 Feb 20;26(1):407. doi: 10.1186/s12913-026-14228-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings in people with Stillbirth and Obstetric Complication, run by Haramaya Unversity at 2 sites in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abera Tura, PhD (+251912048026, daberaf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stillbirth (time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06273007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.