Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia
Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia: A Cluster-randomised Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Abstract Hypothesis A safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage
A safe delivery smartphone application distributed to health workers in Ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation
Intervention A safe delivery smartphone application with animated videos to improve clinical management during delivery will be introduced in the intervention clusters
Design Cluster randomized controlled trial with health facilities as the unit of randomization
Area Nole Kaba, Haru, Homa, Genji and Gimbie districts in Ethiopia
Population Pregnant women and their newborns delivered in a randomized health facility. For secondary outcomes health workers at randomized health facilities.
Sample size 77 health facilities with minimum 2 health workers per facility and 30 deliveries per health worker
Duration Pregnant women will be enrolled at delivery and followed to 7 days postpartum
Outcomes Primary outcomes are perinatal mortality and postpartum haemorrhage. Secondary outcomes are health workers knowledge and skills
Study time Data collection expected from September 2013 to September 2014
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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København V, Dinamarca, 1658
- University of Copenhagen
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
• Women in active labor
Exclusion Criteria:
• None
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Safe Delivery Smartphone Application
The safe delivery smartphone application is designed to train midwives and other birth attendants in developing countries in management of normal and complicated deliveries.
The safe delivery smartphone application will be introduced to health workers in the intervention clusters.
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The safe delivery smartphone application is designed to train midwives and other birth attendants in developing countries in management of normal and complicated deliveries.
The application is furthermore intended as a reference tool that could be used during clinical work for example for preparation before attending a birth, in a situation when a complication occurs, or for debriefing and self-evaluation after a complication.
The application features four animated videos with clinical instructions of 3-8 minutes duration and written lists of essential obstetric drugs (indications, contraindications, dosage and administration and side effects) and essential equipment for a safe delivery.
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Sem intervenção: Control
Health workers in the control clusters will not have access to the Safe Delivery App
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Perinatal mortality (stillbirth and early neonatal death)
Prazo: Participants will be followed from delivery until 7 days postpartum
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Participants will be followed from delivery until 7 days postpartum
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Postpartum haemorrhage
Prazo: Participants will be followed from delivery until two hours postpartum
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Participants will be followed from delivery until two hours postpartum
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Health workers clinical performance in active management of third stage of labour, postpartum haemorrhage and manual removal of placenta
Prazo: 0, 6 and 12 months
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0, 6 and 12 months
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Health workers clinical performance in management of neonatal resuscitation
Prazo: 0, 6 and 12 months
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0, 6 and 12 months
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Health workers knowledge of management of active management of third stage of labour, manual removal of placenta and postpartum haemorrhage
Prazo: 0, 6 and 12 months
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0, 6 and 12 months
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Health workers knowledge of management of neonatal resuscitation
Prazo: 0, 6 and 12 months
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0, 6 and 12 months
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Outras medidas de resultado
Medida de resultado |
Prazo |
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Mortality stratified according to gestational age and birth weight
Prazo: Participants will be followed from delivery until 7 days postpartum
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Participants will be followed from delivery until 7 days postpartum
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Use of the Safe Delivery application (when, how much and by whom)
Prazo: Participants will be followed during the 12 months trial period
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Participants will be followed during the 12 months trial period
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Process indicators of services provided
Prazo: Participants will be followed from delivery until 7 days postpartum
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Participants will be followed from delivery until 7 days postpartum
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SafeDeliveryApp
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