Evaluation of Maternal & Newborn Health Simulation Lab Centers of Excellence in Nepal

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Conditions studied: Post Partum Hemorrhage, Asphyxia; Fetal, Maternal-Fetal Relations

In brief

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.

Key facts

Study ID

NCT06577922

Run by

One Heart Worldwide

People needed

1464

Starts

2024-05-01

Expected to finish

2026-07-31

Last updated by the study team

2024-09-03

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Women with Postpartum Hemorrhage (PPH) referred from other hospital, babies born outside of study hospital, and newborns with congenital abnormalities will be excluded.

Where it is running

• Paropakar Maternity and Women's Hospital, Koshi Hospital, Narayani Hospital, Province Hospital Surkhet, BPKIHS, Pokhara Academy of health sciences, and Madhesh Institute of Health Sciences — Kathmandu, Bagmati, Nepal (enrolling)

Full record on ClinicalTrials.gov

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