NCT05866016

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

May 1, 2023

Last Update Submit

November 29, 2024

Conditions

Outcome Measures

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.

    "1 year"

Secondary Outcomes (1)

  • Cost-benefit analysis

    "2 years"

Study Arms (2)

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.

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.

Behavioral: Skill birth attendant training

Interventions

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.

Skill birth attendants who trained on existing standard training packageSkill birth attendants who trained on new modular training package

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Health Directorate

Pokhara, Gandaki, 000, Nepal

RECRUITING

Khim Bahadur Khadka

Pokhara, Gandaki, 202001, Nepal

RECRUITING

Study Officials

  • Khim Bahadur Khadka, MPH

    MoHP, HD, Gandaki

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Khim Bahadur Khadka, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The outcomes assessor and care provider will be masked to minimize the biases. Trainers will be outcomes assessors and trainees who complete modular training and provide maternal and child health services are considered as care providers.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The competencies of skilled birth attendants who receive modular training will be compared with those of skilled birth attendants who receive existing standard training.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 19, 2023

Study Start

June 15, 2023

Primary Completion

December 1, 2024

Study Completion

February 1, 2025

Last Updated

December 3, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations