- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01945931
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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København V, Danmark, 1658
- University of Copenhagen
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
• Women in active labor
Exclusion Criteria:
• None
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Ingen indgriben: Control
Health workers in the control clusters will not have access to the Safe Delivery App
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Perinatal mortality (stillbirth and early neonatal death)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Health workers clinical performance in active management of third stage of labour, postpartum haemorrhage and manual removal of placenta
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 0, 6 and 12 months
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0, 6 and 12 months
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Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Mortality stratified according to gestational age and birth weight
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SafeDeliveryApp
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