Evaluation of Maternal & Newborn Health Simulation Lab Centers of Excellence in Nepal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorOne Heart Worldwide
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All women who have recently delivered in the study hospital via vaginal delivery
Newborn delivered at the same hospital with gestational age ≥ 37 weeks, birth weight ≥2500 gm, and a fetal heart sound present at the time of admission
Maternal and Newborn Health staff working in selected hospitals for at least 3 months
Disqualifiers
Women with Postpartum Hemorrhage (PPH) referred from other hospital, babies born outside of study hospital, and newborns with congenital abnormalities will be excluded.
Trial design
Design model
Sequential
Treatments tested in this trial
Establishment of a simulation lab and provision of simulation based trainings
Other interventionIn 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.
Treatment groups
1,464 Participants
are divided into 2 treatment groupsGroup A: Pre-intervention groupNo intervention 0 interventions
Group B: Post-intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of women with primary postpartum hemorrhage after vaginal delivery
Daily data will be collected by reviewing the hospital records, patient charts and reports.
Time frame
15 months2
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.
Time frame
15 months3
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).
Time frame
6 monthsSecondary outcomes
1
Rate of maternal blood transfusion after primary postpartum hemorrhage
Daily data will be collected by reviewing the hospital records, patient charts and reports.
Time frame
15 monthsSponsors and contacts
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Source ClinicalTrials.gov