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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Maternal Mortality, Perinatal Mortality

Intervention / Treatment
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* Other: Safe Delivery Smartphone Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Women in active labor Exclusion Criteria: • None

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safe Delivery Smartphone Application<br>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. | Other: Safe Delivery Smartphone Application<br>* 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.<br>|
| No Intervention: Control<br>Health workers in the control clusters will not have access to the Safe Delivery App | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal health, perinatal health, mHealth, smartphone, mobile phone, Ethiopia