Postpartum HemorrhageSimHPPNCT05979701
Simulation for the Retention of Skills in the Management of Obstetric Hemorrhages
A study testing Simulation training in people with Postpartum Hemorrhage and Simulation Training, run by Université Evangélique enAfrique.
Trial summary
The aim of this study is to evaluate the retention of knowledge and skills after theory+simulation training versus theoretical training alone in postpartum haemorrhage immediately, 3 months and 6 months after training in South Kivu, in the east of the Democratic Republic of Congo. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Simulation Training, Healthcare Providers
- What is being tested?
- Simulation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Work in one of the selected maternity units
- Have two years' experience
- Be either a gynaecologist, obstetrician, general practitioner, midwife, nurse, anaesthetist or laboratory technician.
Who cannot join
- -
About this study
Official title: Use of Simulation Training Versus Theoretical Learning for the Retention of Knowledge and Skills in the Management of Postpartum Hemorrhage: A Multicenter, Comparative Study in Eastern DRCongo.
The aim of this study is to evaluate the retention of knowledge and skills after theory+simulation training versus theoretical training alone in postpartum haemorrhage immediately, 3 months and 6 months after training in South Kivu, in the east of the Democratic Republic of Congo.
- Being tested
- Simulation training
- Keywords
- OSCE
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation trainingOther
The intervention will consist of training participants through simulation in addition to theoretical training. The simulation will cover 3 themes, including diagnosis of haemorrhage, communication between healthcare providers, management of post-partum haemorrhage and transfusion monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Theoretical education | No intervention | Not described |
| Theoretical education PLUS simulation training | Experimental | Not described Receives: Other: Simulation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score obtained before training and immediatly after training
Difference of mean score obtained before training, immediatly after training using validate qestionnaire
Measured: Before and immediatly after training
Score obtained before training and 3 months after training
Difference of mean score obtained before training and 3 months after training using validated questionnaire
Measured: 3 months after training
Score obtained before training and 6 months after training
Difference of mean score obtained before training and 6 months after training using validated questionnaire
Measured: 6 months after training
Secondary outcomes (1)
OSCE (Objective Structural Clinical Exam) Score
Difference of OSCE mean score obtained before training and 6 months
Measured: Immediatly and 6 months after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start15 Aug 2023 (estimated)
- Primary completion15 Jan 2024 (estimated)
- Study completion15 May 2024 (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 Postpartum HemorrhageStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Evangélique enAfrique
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers
- Responsible party
- Principal investigator, Cikwanine Buhendwa Jean Paul, Université Evangélique enAfrique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979701
- Sponsor's protocol ID
- 001
- Acronym
- SimHPP
- Status last verified
- Jun 2023
- First submitted
- 29 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cikwanine JPB, Mukwege D, Mongwa J, Shalamba EM, Maroyi R, Yoyu JT, Martin L. An assessment of the effects of simulation training on management of postpartum hemorrhage: short- and long-term impact on knowledge retention, skills and teamwork in the Democratic Republic of Congo. BMC Med Educ. 2025 May 26;25(1):774. doi: 10.1186/s12909-025-07393-3.
PubMed 40420075
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Simulation Training Versus Theoretical Learning for the Retention of Knowledge and Skills in the Management of Postpartum Hemorrhage: A Multicenter, Comparative Study in Eastern DRCongo.
- ClinicalTrials.gov ID
- NCT05979701
- Acronym / sponsor ID
- SimHPP / 001
- Keywords
- OSCE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université Evangélique enAfriqueUniversity, hospital or other
- Collaborators
- University Hospital, Angers
- Study start
- 15 Aug 2023 (estimated)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 7 Aug 2023 (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.
The aim of this study is to evaluate the retention of knowledge and skills after theory+simulation training versus theoretical training alone in postpartum haemorrhage immediately, 3 months and 6 months after training in South Kivu, in the east of the Democratic Republic of Congo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Theoretical education | No intervention | – |
| Theoretical education PLUS simulation training | Experimental | Other: Simulation training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Work in one of the selected maternity units
- Have two years' experience
- Be either a gynaecologist, obstetrician, general practitioner, midwife, nurse, anaesthetist or laboratory technician.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Simulation trainingThe intervention will consist of training participants through simulation in addition to theoretical training. The simulation will cover 3 themes, including diagnosis of haemorrhage, communication between healthcare providers, management of post-partum haemorrhage and transfusion monitoring. | Other | Theoretical education PLUS simulation training |
Primary outcome
Score obtained before training and immediatly after training
Time frame: Before and immediatly after training
Difference of mean score obtained before training, immediatly after training using validate qestionnaire
Score obtained before training and 3 months after training
Time frame: 3 months after training
Difference of mean score obtained before training and 3 months after training using validated questionnaire
Score obtained before training and 6 months after training
Time frame: 6 months after training
Difference of mean score obtained before training and 6 months after training using validated questionnaire
1 secondary outcome
OSCE (Objective Structural Clinical Exam) Score
Time frame: Immediatly and 6 months after training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 40420075Cikwanine JPB, Mukwege D, Mongwa J, Shalamba EM, Maroyi R, Yoyu JT, Martin L. An assessment of the effects of simulation training on management of postpartum hemorrhage: short- and long-term impact on knowledge retention, skills and teamwork in the Democratic Republic of Congo. BMC Med Educ. 2025 May 26;25(1):774. doi: 10.1186/s12909-025-07393-3.
- Individual participant dataSharing planned: Undecided
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation training in people with Postpartum Hemorrhage and Simulation Training, run by Université Evangélique enAfrique.
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 3 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score obtained before training and immediatly after training (time frame: Before and immediatly after training). The study lists 3 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 NCT05979701, 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 14 Aug 2023.