Evaluation of Maternal & Newborn Health Simulation Lab Centers of Excellence in Nepal
NCT06577922 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1464
Last updated 2024-09-03
Summary
Postpartum hemorrhage and birth asphyxia are the leading causes of maternal and neonatal mortalities worldwide. Prevention and adequate treatment are, therefore crucial. While Nepal has made significant improvements in maternal and neonatal health, these efforts are insufficient to achieve the Sustainable Development Goal 3. Several studies have revealed critical gaps in the knowledge and clinical skills of maternal and neonatal health (MNH) providers in Nepal, likely due to limited clinical experience and practical exposure. Therefore, One Heart Worldwide is implementing the 'Maternal and Newborn Health Simulation Lab Centers of Excellence' project in 7 referral hospitals of Nepal wherein in simulation labs will be established and simulation-based training will be provided to hospital staff with a focus on essential care of labor and birth, bleeding after birth, and helping babies breathe modules. This implementation study will evaluate the project implementation and effectiveness using a REAIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. A mixed-methods approach will be used to evaluate each component of RE-AIM using a quasi-experimental pre-test and post-test design. The pre-test data collection will be of 6 months' duration. During this phase, the investigators will collect daily data on maternal and neonatal health outcomes (Post-partum hemorrhage (PPH) incidence, proportion of newborns with APGAR score\<7 at 5 minutes' assessment, and rate of maternal blood transfusion after PPH), and also assess the skills assessment scores of the MNH service providers. After the completion of pre-test data collection, training will be provided to MNH service providers of the hospital in the established simulation labs. The daily MNH routine data collection will continue during project implementation phase, and till six months after the training MNH service providers of the hospitals. In addition to the assessments done in the pre-test, the investigators will also assess the reach, implementation status, challenges, utilization, and maintenance of established simulation labs. The post-test assessment of skills of MNH service providers will be conducted six months after the completion of the in-hospital trainings. Written informed consent will be obtained from the study participants. For the quantitative data, descriptive and inferential statistical methods will be used for data analysis. Qualitative data will be analyzed using thematic analysis supported by NVIVO 12 software.
Conditions
- Post Partum Hemorrhage
- Asphyxia; Fetal
- Maternal-Fetal Relations
Interventions
- OTHER
-
Establishment of a simulation lab and provision of simulation based trainings
In each hospital, the investigators will perform an initial need assessment to identify the existing skills labs' space, equipment and trained human resources. Then, maternal and neonatal health simulation labs will be established in each hospital. One simulation lab will have 5 rooms- one auditorium hall, one debrief room, two simulation rooms, and one high fidelity simulation room. Equipment and manikins required for practicing maternal and neonatal health related skills will be installed in the simulation lab, along with guidance/ checklists for skills practice. After completion of lab set-up, trainings will be provided to trainers/ MNH staff of each hospital on simulation based methodology, especially focusing on Essential Care for Labor and Birth (ECLB), Bleeding after Birth (BAB), and Helping Babies Breathe (HBB) modules. Similarly, the investigators will also provide training for simulation lab operation and maintenance.
Sponsors & Collaborators
-
One Heart Worldwide
lead OTHER
Principal Investigators
-
Surya Bhatta, Masters · One Heart Worldwide
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-05-01
- Primary Completion
- 2026-07-31
- Completion
- 2026-07-31
Countries
- Nepal
Study Locations
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