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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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København V, Danimarca, 1658
- University of Copenhagen
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
• Women in active labor
Exclusion Criteria:
• None
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Nessun intervento: Control
Health workers in the control clusters will not have access to the Safe Delivery App
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Perinatal mortality (stillbirth and early neonatal death)
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Health workers clinical performance in active management of third stage of labour, postpartum haemorrhage and manual removal of placenta
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 0, 6 and 12 months
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0, 6 and 12 months
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Altre misure di risultato
Misura del risultato |
Lasso di tempo |
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Mortality stratified according to gestational age and birth weight
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SafeDeliveryApp
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