Evaluation of Maternal & Newborn Health Simulation Lab Centers of Excellence in Nepal
NCT Number: NCT06577922
Acronym: SLAB
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Partum Hemorrhage|Asphyxia; Fetal|Maternal-Fetal Relations
Sponsor: One Heart Worldwide
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1464
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-05-01
Completion Date: 2026-07-31

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\&amp;lt;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.

Primary Outcome Measures: Proportion of women with primary postpartum hemorrhage after vaginal delivery, Daily data will be collected by reviewing the hospital records, patient charts and reports., 15 months|Proportion of newborns with APGAR score <7 at 5 minutes' assessment, Daily data will be collected by reviewing the hospital records, patient charts and reports., 15 months|Skills score of maternal and newborn health service providers on Essential Care for Labor and Birth (ECLB), Bleeding after Birth (BAB), and Helping Babies Breathe (HBB) module., Skills will be measured by experts before and 6 months after the simulation based trainings. The higher the scores, better the outcomes. The maximum obtainable score will be 100% (scores will be converted into percentage)., 6 months
Secondary Outcome Measures: Rate of maternal blood transfusion after primary postpartum hemorrhage, Daily data will be collected by reviewing the hospital records, patient charts and reports., 15 months