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

University of Copenhagen

Status: Completed

Conditions: Perinatal Mortality; Maternal Mortality

Treatments: Other: Safe Delivery Smartphone Application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01945931

SafeDeliveryApp

Details and patient eligibility

About

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.

Full 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

Enrollment: 3,601 patients

Sex: Female

Ages: 10 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women in active labor

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,601 participants in 2 patient groups

Safe Delivery Smartphone Application

Experimental group

Description:

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.

Treatment:

Other: Safe Delivery Smartphone Application

Control

No Intervention group

Description:

Health workers in the control clusters will not have access to the Safe Delivery App