ClinicalTrials.gg
RecruitingNCT05866016Updated Dec 3, 2024

Effect of Skill Birth Attendant Training to Improve the Competency of Service Providers

An interventional study of Skill birth attendant training in Competencies of Midwives and Cost-benefit Analysis of Modular Training, sponsored by Ministry of Health Gandaki Province, Nepal. Recruiting at 2 sites in Nepal. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Ministry of Health Gandaki Province, Nepal · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Competencies of Midwives
  • Cost-benefit Analysis of Modular Training
03

In context

Lead sponsor

This is the only study on the registry with Ministry of Health Gandaki Province, Nepal as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Skill birth attendants who trained on new modular training package

    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.

    Behavioral: Skill birth attendant training

  • Active comparator
    Skill birth attendants who trained on existing standard training package

    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.

    Behavioral: Skill birth attendant training

Interventions

  • BehavioralSkill birth attendant training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: "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).

    Time frame: "2 years"

07

Study locations

2 of 2 sites recruiting
  • Health Directorate
    Pokhara, Gandaki 000, Nepal
    Recruiting
    • Khim Bahadur Khadka, MPH · Contactkhimkhadka2012@gmail.com · +977 9856065453
    • Khim Bahadur Khadka, MPH · Principal investigator
  • Khim Bahadur Khadka
    Pokhara, Gandaki 202001, Nepal
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2023 (actual). Primary completion is estimated for Dec 2024, 18 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2023
First posted
May 19, 2023
StartActual
Jun 15, 2023
Primary completionEst.
Dec 2024
CompletionEst.
Feb 2025
Last update
Dec 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05866016
Lead sponsor
Ministry of Health Gandaki Province, Nepal
Collaborators
Ministry of Health and Population, Nepal, Ludwig-Maximilians - University of Munich
Responsible party
Sponsor
First posted
May 19, 2023
Start date
Jun 15, 2023
Primary completion
Dec 2024 (estimated)
Completion
Feb 2025 (estimated)
Last update
Dec 3, 2024

Study contacts

Khim Bahadur Khadka, MPH
Contact
khimkhadka2012@gmail.com
9856065453
Khim Bahadur Khadka, MPH
principal investigator · MoHP, HD, Gandaki

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion