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

Primary Purpose

Maternal Mortality, Perinatal Mortality

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Safe Delivery Smartphone Application
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maternal Mortality focused on measuring Maternal health, perinatal health, mHealth, smartphone, mobile phone, Ethiopia

Eligibility Criteria

10 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

• Women in active labor

Exclusion Criteria:

• None

Sites / Locations

  • University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Safe Delivery Smartphone Application

Control

Arm 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.

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

Outcomes

Primary Outcome Measures

Perinatal mortality (stillbirth and early neonatal death)
Postpartum haemorrhage

Secondary Outcome Measures

Health workers clinical performance in active management of third stage of labour, postpartum haemorrhage and manual removal of placenta
Health workers clinical performance in management of neonatal resuscitation
Health workers knowledge of management of active management of third stage of labour, manual removal of placenta and postpartum haemorrhage
Health workers knowledge of management of neonatal resuscitation

Full Information

First Posted
September 5, 2013
Last Updated
October 6, 2015
Sponsor
University of Copenhagen
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01945931
Brief Title
Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia
Official Title
Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia: A Cluster-randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Mortality, Perinatal Mortality
Keywords
Maternal health, perinatal health, mHealth, smartphone, mobile phone, Ethiopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3601 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safe Delivery Smartphone Application
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Health workers in the control clusters will not have access to the Safe Delivery App
Intervention Type
Other
Intervention Name(s)
Safe Delivery Smartphone Application
Intervention 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 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.
Primary Outcome Measure Information:
Title
Perinatal mortality (stillbirth and early neonatal death)
Time Frame
Participants will be followed from delivery until 7 days postpartum
Title
Postpartum haemorrhage
Time Frame
Participants will be followed from delivery until two hours postpartum
Secondary Outcome Measure Information:
Title
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
Title
Health workers clinical performance in management of neonatal resuscitation
Time Frame
0, 6 and 12 months
Title
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
Title
Health workers knowledge of management of neonatal resuscitation
Time Frame
0, 6 and 12 months
Other Pre-specified Outcome Measures:
Title
Mortality stratified according to gestational age and birth weight
Time Frame
Participants will be followed from delivery until 7 days postpartum
Title
Use of the Safe Delivery application (when, how much and by whom)
Time Frame
Participants will be followed during the 12 months trial period
Title
Process indicators of services provided
Time Frame
Participants will be followed from delivery until 7 days postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Women in active labor Exclusion Criteria: • None
Facility Information:
Facility Name
University of Copenhagen
City
København V
ZIP/Postal Code
1658
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27322089
Citation
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.
Results Reference
derived

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

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