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

Not Applicable

Completed

• Conditions: Maternal Mortality; Perinatal Mortality
• Interventions: Other: Safe Delivery Smartphone Application

• Registration Number: NCT01945931
• Lead Sponsor: University of Copenhagen

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 Description

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

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-05
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3601

Inclusion Criteria

• Women in active labor

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Safe Delivery Smartphone Application	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.

Primary Outcome Measures

Name	Time	Method
Perinatal mortality (stillbirth and early neonatal death)	Participants will be followed from delivery until 7 days postpartum
Postpartum haemorrhage	Participants will be followed from delivery until two hours postpartum

Secondary Outcome Measures

Name	Time	Method
Health workers clinical performance in active management of third stage of labour, postpartum haemorrhage and manual removal of placenta	0, 6 and 12 months
Health workers clinical performance in management of neonatal resuscitation	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	0, 6 and 12 months
Health workers knowledge of management of neonatal resuscitation	0, 6 and 12 months

Trial Locations

Locations (1)

University of Copenhagen; 🇩🇰 København V, Denmark