Actively Recruiting

Phase Not Applicable
FEMALE
Healthy Volunteers
ID06577922

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

Led by One Heart Worldwide · Updated on 2024-09-03

1464

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Postpartum hemorrhage and birth asphyxia are leading causes of death for mothers and newborns worldwide, especially in low and middle-income countries. While Nepal has improved maternal and neonatal health, gaps remain in healthcare providers' knowledge and skills, likely due to limited practical experience. This study evaluates the implementation and effectiveness of simulation-based training centers in seven referral hospitals in Nepal to improve care for labor, bleeding after birth, and newborn resuscitation using a RE-AIM framework and a quasi-experimental pre- and post-test design. The project establishes high-fidelity simulation labs with multiple rooms and equipment in each hospital, providing training focused on Essential Care for Labor and Birth, Bleeding after Birth, and Helping Babies Breathe modules. Training is given to maternal and newborn health staff, including trainers and simulation lab operators. The intervention group receives this training after an initial pre-test phase. Data collection on maternal and neonatal health outcomes continues throughout pre-test, intervention, and post-test phases. Participants include women delivering vaginally, their newborns, and healthcare providers in the selected hospitals. Data collected include postpartum hemorrhage incidence, neonatal APGAR scores at 5 minutes, and blood transfusion rates after hemorrhage. Skills and team performance of providers are assessed before and six months after training. Qualitative interviews and focus groups explore challenges and implementation status. The study uses daily data collection and statistical analyses, with a total participation duration of about 15 months for outcome monitoring and six months for skill assessment.

CONDITIONS

Brief Title

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

Who Can Participate

FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women who have recently delivered vaginally in the study hospital
  • Newborns delivered at the study hospital with gestational age 37 weeks or more and birth weight 2500 grams or more
  • Maternal and Newborn Health staff working in selected hospitals for at least 3 months
Not Eligible

You will not qualify if you...

  • Women with postpartum hemorrhage referred from other hospitals
  • Babies born outside the study hospital
  • Newborns with congenital abnormalities

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants include women who have recently delivered vaginally, newborns delivered at the hospital with gestational age of 37 weeks or more and birth weight of 2500 grams or more, and maternal and newborn health staff working in selected hospitals for at least 3 months.

Establishment of Simulation Lab and Training

Duration - Initial setup and training phase (duration not explicitly stated)

Participants involved in the trial will experience the establishment of maternal and neonatal health simulation labs in each hospital, including equipment installation and training of health care providers on simulation-based methods focusing on essential maternal and newborn care skills.

Training sessions and simulation lab operation trainings provided to hospital staff; specific visit schedule not provided.

Effectiveness Assessment

Duration - 6 months after completion of intervention

Participants undergo skill assessments and team performance evaluations before and 6 months after the intervention to measure changes in competence and team communication in managing maternal and newborn health emergencies.

Multiple assessments including Objective Structured Clinical Examinations and team performance evaluations conducted by trained simulation experts.

Maternal and Neonatal Outcomes Data Collection

Duration - 6 months pre-intervention and 6 months post-intervention (total 12 months)

Participants' maternal and neonatal health outcomes, such as incidence of postpartum hemorrhage, blood transfusion rates, and newborn APGAR scores, are monitored and recorded during the 6 months before and after the intervention to assess the impact of the simulation labs.

Continuous data collection from hospital records and patient charts during delivery and postpartum periods.

Qualitative Assessments and Maintenance

Duration - Throughout the study period

Participants involved in interviews and focus groups share their experiences, challenges, and recommendations regarding the simulation labs; hospital actions for sustaining simulation-based training are also observed.

In-depth interviews and focus group discussions conducted at various times; specific visit schedule not provided.

Trial Site Locations

Total: 1 location

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, Nepal, 44700

Actively Recruiting

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Research Team

N

Nashna Maharjan, MHPE

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Published Research Related To This Trial

Assessment of facility and health worker readiness to provide quality antenatal, intrapartum and postpartum care in rural Southern Nepal.

Tsering P Lama, Melinda K Munos, Joanne Katz...

https://pubmed.ncbi.nlm.nih.gov/31906938

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.

Emmanuel Ugwa, Emmanuel Otolorin, Mark Kabue...

https://pubmed.ncbi.nlm.nih.gov/30103761