Clinical Trial: Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia: A Cluster-randomised Controlled Trial

Brief Summary: 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.

Detailed Summary:

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


Sponsor: University of Copenhagen

Current Primary Outcome:

  • Perinatal mortality (stillbirth and early neonatal death) [ Time Frame: Participants will be followed from delivery until 7 days postpartum ]
  • Postpartum haemorrhage [ Time Frame: Participants will be followed from delivery until two hours postpartum ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Health workers clinical performance in active management of third stage of labour, postpartum haemorrhage and manual removal of placenta [ Time Frame: 0, 6 and 12 months ]
  • Health workers clinical performance in management of neonatal resuscitation [ Time Frame: 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 [ Time Frame: 0, 6 and 12 months ]
  • Health workers knowledge of management of neonatal resuscitation [ Time Frame: 0, 6 and 12 months ]


Original Secondary Outcome: Same as current

Information By: University of Copenhagen

Dates:
Date Received: September 5, 2013
Date Started: September 2013
Date Completion:
Last Updated: October 6, 2015
Last Verified: October 2015