NCT05979701

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

August 14, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

July 29, 2023

Last Update Submit

August 9, 2023

Conditions

Keywords

OSCE

Outcome Measures

Primary Outcomes (3)

  • Score obtained before training and immediatly after training

    Difference of mean score obtained before training, immediatly after training using validate qestionnaire

    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

    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

    6 months after training

Secondary Outcomes (1)

  • OSCE (Objective Structural Clinical Exam) Score

    Immediatly and 6 months after training

Study Arms (2)

Theoretical education

NO INTERVENTION

Theoretical education PLUS simulation training

EXPERIMENTAL
Other: Simulation training

Interventions

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.

Theoretical education PLUS simulation training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2023

First Posted

August 7, 2023

Study Start

August 15, 2023

Primary Completion

January 15, 2024

Study Completion

May 15, 2024

Last Updated

August 14, 2023

Record last verified: 2023-06