Evaluating an internal quality assurance process in midwifery education

ISRCTN	ISRCTN14492910
DOI	https://doi.org/10.1186/ISRCTN14492910
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	University of Gothenburg
Funder	United Nations Population Fund

Submission date: 20/08/2024
Registration date: 26/08/2024
Last edited: 12/09/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The World Health Organization and the International Confederation of Midwives stress the critical role of accreditation in improving the quality of midwifery education. In many high-income countries, midwifery education programmes regularly perform self-assessments to maintain a learning environment where the programme content, learning opportunities, and facilities effectively align with educational goals. These self-assessments provide valuable insights and recommendations for enhancing educational quality in anticipation of formal accreditation.
However, less than half of the world's countries have established accreditation systems for midwifery education. In many low-income countries, midwifery education programs fall short of meeting accreditation standards. Accreditation serves to formally recognize the processes that ensure education programmes comply with nationally established standards, thereby ensuring that graduates achieve the required minimum level of competence. Despite its importance, research in this area remains limited. To strengthen midwifery education in Bangladesh, the government has initiated measures for an internal quality assurance self-assessment process for midwifery education programmes, in addition to the national accreditation system. The overall aim of this study is to evaluate the internal quality assurance process in midwifery education aimed at achieving national accreditation standards in Bangladesh. The specific aims are to evaluate to what extent education standards are met in the internal quality assurance process at midwifery education institutions. The study aims to determine the effectiveness of the internal quality assurance process in producing competent and confident educators and midwives and identify contextual factors influencing the internal quality assurance process to reach national accreditation standards for midwifery education.

Who can participate?
Midwifery faculty members, such as clinical supervisors, librarians, computer lab and clinical simulation managers, all midwifery educators, and all final-semester students at 31 public and private midwifery education institutions.

What does the study involve?
This study will be directed by the principles of process evaluation for complex interventions. An internal quality assurance self-assessment intervention, and to ensure sustainable implementation the Plan-Do-Study-Act cycle, will be introduced across 31 private and public midwifery education institutions. Data collection will involve self-assessment questionnaires and focus group discussions, with participants comprising midwifery faculty and final-semester students.

What are the possible benefits and risks of participating?
The benefits of participating are to contribute to generating new evidence which in turn can lead to strengthening internal quality assurance of midwifery education in Bangladesh. There are no evident risks for the participants

Where is the study run from?
University of Gothenburg (Sweden)

When is the study starting and how long is it expected to run for?
August 2023 to December 2028

Who is funding the study?
United Nations Population Fund (UNFPA)

Who is the main contact?
Malin Bogren, malin.bogren@gu.se

Contact information

Dr Malin Bogren
Scientific, Principal investigator

Institute of Health and Care Sciences
Sahlgrenska Academy
University of Gothenburg
Arvid Wallgrens backe, House 1
Gothenburg
413 46
Sweden

ORCID ID	0000-0003-2432-8097
Phone	+46 (0)738099508
Email	malin.bogren@gu.se

Mrs Frida Berg
Public, Scientific

Institute of Health and Care Sciences
Sahlgrenska Academy
University of Gothenburg
Arvid Wallgrens backe, House 1
Gothenburg
413 46
Sweden

ORCID ID	0009-0003-9293-8767
Phone	+46 (0)708397906
Email	frida.berg@gu.se

Prof Kerstin Erlandsson
Scientific

School of Health and Welfare
Dalarna University
Falun
791 88
Sweden

ORCID ID	0000-0002-6910-7047
Phone	+46 (0)23-77 84 11
Email	ker@du.se

Study information

Primary study design	Observational
Study design	Longitudinal exploratory design using a process evaluation framework
Secondary study design	Longitudinal study
Study type	Participant information sheet
Scientific title	Evaluating an internal quality assurance process for achieving national accreditation standards in midwifery education
Study objectives	It is hypothesized that implementing an internal quality assurance process will improve the quality of midwifery education programmes, producing competent and confident educators and midwives and thereby meeting national accreditation standards.
Ethics approval(s)	Approved 30/05/2024, National Ethical Committee in Sweden (Etikprövningsmyndigheten) (Box 2110, Uppsala, 75002, Sweden; +46 (0)10-4750800; registrator@etikprovning.se), ref: D-no: 2024-02510-01-583296
Health condition(s) or problem(s) studied	Evaluating internal quality assurance processes in midwifery education
Intervention	The intervention consists of an internal quality assurance process to be integrated into education institutions to enhance the quality of midwifery education. Through a recurrent self-assessment, the faculty assess their respective education programmes against national and international standards. The faculty within the midwifery education programmes internally analyse the achievements of the self-assessment, indicating which standards are met, partially met, and unmet and what changes need to be prioritized in the next cycle. Based on the yearly self-assessment findings, the faculty makes a recurrent activity plan. The learning from one assessment guides the plan that follows.
Intervention type	Behavioural
Primary outcome measure(s)	1. The internal quality assurance process at the selected educational institutions will be measured using six categories: i) Program management; ii) Faculty; iii) Students; iv) Midwifery program and curriculum; v) Resources; and vi) Quality improvements, at baseline (2024) and endline (2027). 2. Effectiveness in producing midwifery educators who are competent and confident in delivering the World Health Organization’s educator competencies, as well as competent and confident final-semester students at selected institutions, will be measured through self-assessment at baseline (1st year 2024) and endline (3rd year 2027).
Key secondary outcome measure(s)	Contextual factors influencing the internal quality assurance process to reach national accreditation standards for midwifery education will be measured at baseline (1st year 2024)
Completion date	31/12/2028

Eligibility

Participant type(s)	Employee, Learner/student
Age group	Adult
Lower age limit	18 Years
Upper age limit	64 Years
Sex	All
Target sample size at registration	1700
Key inclusion criteria	Employed or student at one of the selected higher education institutions in Bangladesh 1. Management 2. Midwifery educator 3. Clinical mentor 4. Librarians 5. Responsible for the computer lab 6. Head of the skills lab 7. Final year midwifery students
Key exclusion criteria	1. Not employed or a student at one of the selected institutions 2. Participants who do not want to participate
Date of first enrolment	01/05/2024
Date of final enrolment	31/12/2026

Locations

Countries of recruitment

Bangladesh

Study participating centre

Government of the People´s Reprublic of Bangladesh, Directorate General of Nursing and Midwifery

IPH School Road Mohakhali
Dhaka
1212
Bangladesh

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository, Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to the need to protect the faculty and individuals participating in the study. All results will be presented at the group level and will be anonymized.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other files	Interim results	12/09/2025	12/09/2025	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN14492910_InterimResults_12Sep25.docx: Interim results

Editorial Notes

12/09/2025: Interim results added.
20/08/2024: Study's existence confirmed by the National Ethical Committee in Sweden (Etikprövningsmyndigheten).