Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia
NCT ID: NCT01945931
Last Updated: 2015-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3601 participants
INTERVENTIONAL
2013-09-30
2015-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Control
Health workers in the control clusters will not have access to the Safe Delivery App
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
10 Years
45 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
University of Copenhagen
OTHER
Responsible Party
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Stine Lund, MD, PhD fellow
MD, PhD fellow
Locations
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University of Copenhagen
København V, , Denmark
Countries
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References
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Christiansen AH, Sorensen BL, Boas IM, Bedesa T, Fekede W, Nielsen HS, Lund S. The impact of the Safe Delivery Application on knowledge and skills managing postpartum haemorrhage in a low resource setting: a cluster randomized controlled trial in West Wollega region, Ethiopia. Reprod Health. 2023 Jun 16;20(1):91. doi: 10.1186/s12978-023-01635-7.
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.
Other Identifiers
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SafeDeliveryApp
Identifier Type: -
Identifier Source: org_study_id
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