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

NCT06577922 | Recruiting DMC

• 1 other identifier: OHW2
• Study Type: interventional
• Target: 1,464
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Simulation; Simulation based education; Maternal health; Neonatal health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Rate of maternal blood transfusion after primary postpartum hemorrhage

  15 months

Study Arms (2)

Pre-intervention group

NO INTERVENTION

This is the group before the intervention

Post-intervention group

EXPERIMENTAL

This is the group after intervention.

Other: Establishment of a simulation lab and provision of simulation based trainings

Interventions

Establishment of a simulation lab and provision of simulation based trainings OTHER

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.

Post-intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• One Heart Worldwide: lead

Study Sites (1)

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, 44700, Nepal

RECRUITING

Related Publications (7)

• Lama TP, Munos MK, Katz J, Khatry SK, LeClerq SC, Mullany LC. Assessment of facility and health worker readiness to provide quality antenatal, intrapartum and postpartum care in rural Southern Nepal. BMC Health Serv Res. 2020 Jan 6;20(1):16. doi: 10.1186/s12913-019-4871-x.

  PMID: 31906938 BACKGROUND

• Rajbhandari R, Rai S, Hathi S, Thapa R, Rai I, Shrestha A. The quality of skilled birth attendants in Nepal: High aspirations and ground realities. PLoS One. 2019 Apr 4;14(4):e0214577. doi: 10.1371/journal.pone.0214577. eCollection 2019.

  PMID: 30947314 BACKGROUND

• Acharya D, Paudel R. Assessment of Critical Knowledge on Maternal and Newborn care Services among Primary Level Nurse Mid-wives in Kapilvastu District of Nepal. Kathmandu Univ Med J (KUMJ). 2015 Oct-Dec;13(52):351-6. doi: 10.3126/kumj.v13i4.16836.

  PMID: 27423287 BACKGROUND

• Acharya D, Paudel R, Gautam K, Gautam S, Upadhyaya T. Knowledge of Maternal and Newborn Care Among Primary Level Health Workers in Kapilvastu District of Nepal. Ann Med Health Sci Res. 2016 Jan-Feb;6(1):27-32. doi: 10.4103/2141-9248.180266.

  PMID: 27144073 BACKGROUND

• Benner P, Hughes RG, Sutphen M. Clinical Reasoning, Decisionmaking, and Action: Thinking Critically and Clinically. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 6. Available from http://www.ncbi.nlm.nih.gov/books/NBK2643/

  PMID: 21328745 BACKGROUND

• Gillespie M, Peterson BL. Helping novice nurses make effective clinical decisions: the situated clinical decision-making framework. Nurs Educ Perspect. 2009 May-Jun;30(3):164-70.

  PMID: 19606659 BACKGROUND

• Ugwa E, Otolorin E, Kabue M, Ishola G, Evans C, Oniyire A, Olisaekee G, Onwe B, LeFevre AE, Bluestone J, Orji B, Yenokyan G, Okoli U. Simulation-based low-dose, high-frequency plus mobile mentoring versus traditional group-based training approaches on day of birth care among maternal and newborn healthcare providers in Ebonyi and Kogi States, Nigeria; a randomized controlled trial. BMC Health Serv Res. 2018 Aug 13;18(1):630. doi: 10.1186/s12913-018-3405-2.

  PMID: 30103761 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage; Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Surya Bhatta, Masters

  One Heart Worldwide

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nashna Maharjan, MHPE

CONTACT

977-01-5188355; nashna@oneheartworldwide.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)