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

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.

Study Overview

• Status: Completed
• Conditions: Maternal Mortality; Perinatal Mortality
• Intervention / Treatment: Other: Safe Delivery Smartphone Application

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 Type: Interventional
• Enrollment (Actual): 3601
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • København V, Denmark, 1658
    • University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women in active labor

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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 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.
No Intervention: Control; Health workers in the control clusters will not have access to the Safe Delivery App

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Mortality stratified according to gestational age and birth weight	Participants will be followed from delivery until 7 days postpartum
Use of the Safe Delivery application (when, how much and by whom)	Participants will be followed during the 12 months trial period
Process indicators of services provided	Participants will be followed from delivery until 7 days postpartum

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Lund S, Boas IM, Bedesa T, Fekede W, Nielsen HS, Sorensen BL. Association Between the Safe Delivery App and Quality of Care and Perinatal Survival in Ethiopia: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):765-71. doi: 10.1001/jamapediatrics.2016.0687.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: September 16, 2013
• First Posted (Estimate): September 19, 2013

Study Record Updates

• Last Update Posted (Estimate): October 8, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: smartphone; mHealth; Ethiopia; mobile phone; Maternal health; perinatal health
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Parental Death; Perinatal Death; Maternal Death
• Other Study ID Numbers: SafeDeliveryApp