Competencies of MidwivesNCT05866016
Effect of Skill Birth Attendant Training to Improve the Competency of Service Providers
A study testing Skill birth attendant training in people with Competencies of Midwives and Cost-benefit Analysis of Modular Training, run by Ministry of Health Gandaki Province, Nepal at 2 sites in Nepal.
Trial summary
This clinical trial's primary goal is to compare birth attendants' competencies. It aims to answer the questions: Does the new modular training package enhance the competencies of skilled birth attendants? Does the competencies of skilled birth attendants relates to improving maternal and neonatal health outcomes in… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Competencies of Midwives, Cost-benefit Analysis of Modular Training
- What is being tested?
- Skill birth attendant training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesNepal
- Study dates
- 15 Jun 2023to Feb 2025
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Health workers should be Auxiliary Nurse Midwives and Nurses working in birthing centers where at least 10 birth managed in the last year
- Health workers (Auxiliary Nurse Midwives and Nurses) who are committed to providing maternal and neonatal health services and priority for permanent service holders.
- Who passes at least the first module (Online module) to participate in modular training
Who cannot join
- Health workers (Auxiliary Nurse Midwives ad Nurses) who do not provide maternal and neonatal health service
- Health workers other than Auxiliary Nurse Midwives and Nurses though they provide maternal neonatal health services in government health facilities
- Health workers working in private health facilities
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal2 sites, 2 recruiting
- Recruiting
Health Directorate
Pokhara, Gandaki, 000
Khim Bahadur Khadka, MPH, +977 9856065453, khimkhadka2012@gmail.com
Khim Bahadur Khadka, MPH
- Recruiting
Khim Bahadur Khadka
Pokhara, Gandaki, 202001
About this study
Official title: Effectiveness of Modular Skilled Birth Attendant Training to Improve the Competencies of Service Providers and Maternal Newborn Health in Nepal: A Randomized Control Pilot Trial
This clinical trial's primary goal is to compare birth attendants' competencies. It aims to answer the questions:
- Does the new modular training package enhance the competencies of skilled birth attendants?
- Does the competencies of skilled birth attendants relates to improving maternal and neonatal health outcomes in Nepal?
- Is this training module a cost-effective intervention?
Participants' knowledge, attitude, and skills will be assessed and it will be compared with standard training groups: Researchers will compare the competencies of birth attendants who receive modular training versus standard training to see if an increment in competencies is associated with maternal and neonatal health outcomes.
- Being tested
- Skill birth attendant training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skill birth attendant trainingBehavioural
It is an intervention targeted to enhance the competencies of Maternal Neonatal Health (MNH) service providers (skilled birth attendants) in Nepal. It is a capacity-building intervention that is expected to contribute to reducing maternal and neonatal morbidities and mortalities by improving the midwifery competencies (knowledge, attitudes, and skills) of MNH service providers.
| Study group | Role | What they receive |
|---|---|---|
| Skill birth attendants who trained on new modular training package | Experimental | Maternal and child health service providers (skilled birth attendants) will be trained using modular training that covers both theory and practical sessions on midwifery skills.
Auxiliary nurse midwives should complete modules 1, 2, and 3 whereas nurses will get modules 1, 2, 3, and 4.
The training will be implemented in National Health Training Center-accredited training sites/ hospitals. Receives: Behavioral: Skill birth attendant training |
| Skill birth attendants who trained on existing standard training package | Active comparator | Maternal and child health service providers (auxiliary nurse midwives and nurses) get training based on the existing standard skilled birth attendant training curriculum of Nepal. This is a two-month-long integrated skill birth attendant package implemented in National Health Training Center-accredited training sites.
The midwifery competencies of these service providers will be assessed and compared with the competencies of experimental groups. Receives: Behavioral: Skill birth attendant training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness assessment of modular skilled birth attendant training package
The health workers who get new modular skill birth attendant training are expected to be more competent to provide midwifery services. Hence, this training is specifically targeted to improve midwifery knowledge, attitudes, and skills.
Measured: "1 year"
Secondary outcomes (1)
Cost-benefit analysis
The associated cost (monetary value) of the new modular and standard training will be calculated and compared with the effect (maternal and neonatal death reduction).
Measured: "2 years"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start15 Jun 2023
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Competencies of MidwivesStudies 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
- The competencies of skilled birth attendants who receive modular training will be compared with those of skilled birth attendants who receive existing standard training.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health Gandaki Province, Nepal
- Sponsor type
- Other government
- Collaborators
- Ministry of Health and Population, Nepal, Ludwig-Maximilians - University of Munich
- Responsible party
- Sponsor
- Investigators
- Khim Bahadur Khadka, MPH, Principal investigator, MoHP, HD, Gandaki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866016
- Sponsor's protocol ID
- Gandaki_MNHstudy_2022_2025
- Status last verified
- Nov 2024
- First submitted
- 1 May 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Modular Skilled Birth Attendant Training to Improve the Competencies of Service Providers and Maternal Newborn Health in Nepal: A Randomized Control Pilot Trial
- ClinicalTrials.gov ID
- NCT05866016
- Acronym / sponsor ID
- Gandaki_MNHstudy_2022_2025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ministry of Health Gandaki Province, NepalOther government
- Collaborators
- Ministry of Health and Population, Nepal, Ludwig-Maximilians - University of Munich
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 19 May 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.
This clinical trial's primary goal is to compare birth attendants' competencies. It aims to answer the questions:
- Does the new modular training package enhance the competencies of skilled birth attendants?
- Does the competencies of skilled birth attendants relates to improving maternal and neonatal health outcomes in Nepal?
- Is this training module a cost-effective intervention?
Participants' knowledge, attitude, and skills will be assessed and it will be compared with standard training groups: Researchers will compare the competencies of birth attendants who receive modular training versus standard training to see if an increment in competencies is associated with maternal and neonatal health outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The competencies of skilled birth attendants who receive modular training will be compared with those of skilled birth attendants who receive existing standard training.
| Arm | Type | Receives |
|---|---|---|
| Skill birth attendants who trained on new modular training package | Experimental | Behavioral: Skill birth attendant trainingMaternal and child health service providers (skilled birth attendants) will be trained using modular training that covers both theory and practical sessions on midwifery skills. Auxiliary nurse midwives should complete modules 1, 2, and 3 whereas nurses will get modules 1, 2, 3, and 4. The training will be implemented in National Health Training Center-accredited training sites/ hospitals. |
| Skill birth attendants who trained on existing standard training package | Active comparator | Behavioral: Skill birth attendant trainingMaternal and child health service providers (auxiliary nurse midwives and nurses) get training based on the existing standard skilled birth attendant training curriculum of Nepal. This is a two-month-long integrated skill birth attendant package implemented in National Health Training Center-accredited training sites. The midwifery competencies of these service providers will be assessed and compared with the competencies of experimental groups. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Health workers should be Auxiliary Nurse Midwives and Nurses working in birthing centers where at least 10 birth managed in the last year
- Health workers (Auxiliary Nurse Midwives and Nurses) who are committed to providing maternal and neonatal health services and priority for permanent service holders.
- Who passes at least the first module (Online module) to participate in modular training
Key exclusion criteria (3 listed)
- Health workers (Auxiliary Nurse Midwives ad Nurses) who do not provide maternal and neonatal health service
- Health workers other than Auxiliary Nurse Midwives and Nurses though they provide maternal neonatal health services in government health facilities
- Health workers working in private health facilities
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 |
|---|---|---|
| Skill birth attendant trainingIt is an intervention targeted to enhance the competencies of Maternal Neonatal Health (MNH) service providers (skilled birth attendants) in Nepal. It is a capacity-building intervention that is expected to contribute to reducing maternal and neonatal morbidities and mortalities by improving the midwifery competencies (knowledge, attitudes, and skills) of MNH service providers. | Behavioural | Skill birth attendants who trained on existing standard training package, Skill birth attendants who trained on new modular training package |
Primary outcome
Effectiveness assessment of modular skilled birth attendant training package
Time frame: "1 year"
The health workers who get new modular skill birth attendant training are expected to be more competent to provide midwifery services. Hence, this training is specifically targeted to improve midwifery knowledge, attitudes, and skills.
1 secondary outcome
Cost-benefit analysis
Time frame: "2 years"
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 3 Dec 2024.
- Individual participant dataSharing planned: No
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.
Khim Bahadur Khadka, MPH principal investigator
MoHP, HD, Gandaki
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skill birth attendant training in people with Competencies of Midwives and Cost-benefit Analysis of Modular Training, run by Ministry of Health Gandaki Province, Nepal at 2 sites in Nepal.
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 3 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 3 Dec 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 Nepal. 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 Khim Bahadur Khadka, MPH (9856065453, khimkhadka2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness assessment of modular skilled birth attendant training package (time frame: "1 year"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2024.