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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
København V, Danmark, 1658
- University of Copenhagen
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
• Women in active labor
Exclusion Criteria:
• None
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Inget ingripande: Control
Health workers in the control clusters will not have access to the Safe Delivery App
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Perinatal mortality (stillbirth and early neonatal death)
Tidsram: Participants will be followed from delivery until 7 days postpartum
|
Participants will be followed from delivery until 7 days postpartum
|
|
Postpartum haemorrhage
Tidsram: Participants will be followed from delivery until two hours postpartum
|
Participants will be followed from delivery until two hours postpartum
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Health workers clinical performance in active management of third stage of labour, postpartum haemorrhage and manual removal of placenta
Tidsram: 0, 6 and 12 months
|
0, 6 and 12 months
|
|
Health workers clinical performance in management of neonatal resuscitation
Tidsram: 0, 6 and 12 months
|
0, 6 and 12 months
|
|
Health workers knowledge of management of active management of third stage of labour, manual removal of placenta and postpartum haemorrhage
Tidsram: 0, 6 and 12 months
|
0, 6 and 12 months
|
|
Health workers knowledge of management of neonatal resuscitation
Tidsram: 0, 6 and 12 months
|
0, 6 and 12 months
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Mortality stratified according to gestational age and birth weight
Tidsram: Participants will be followed from delivery until 7 days postpartum
|
Participants will be followed from delivery until 7 days postpartum
|
|
Use of the Safe Delivery application (when, how much and by whom)
Tidsram: Participants will be followed during the 12 months trial period
|
Participants will be followed during the 12 months trial period
|
|
Process indicators of services provided
Tidsram: Participants will be followed from delivery until 7 days postpartum
|
Participants will be followed from delivery until 7 days postpartum
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SafeDeliveryApp
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .