Perinatal Mortality Clinical Trial
Official title:
Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia: A Cluster-randomised Controlled Trial
The purpose of this trial is to determine if the safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage. It is also the purpose to determine if the 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.
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
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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