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

NCT01945931 | Completed DMC

• 1 other identifier: SafeDeliveryApp
• Study Type: interventional
• Target: 3,601
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Mortality; Perinatal Mortality

Keywords

Maternal health; perinatal health; mHealth; smartphone; mobile phone; Ethiopia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (2)

Safe Delivery Smartphone Application

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Safe Delivery Smartphone Application OTHER

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.

Safe Delivery Smartphone Application

Eligibility Criteria

• Age: 10 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women in active labor

You may not qualify if:

• None

Sponsors & Collaborators

• University of Copenhagen: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Copenhagen

København V, 1658, Denmark

Location

Related Publications (2)

• 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.

  PMID: 37328731 DERIVED

• 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.

  PMID: 27322089 DERIVED

MeSH Terms

Conditions

Maternal Death; Perinatal Death

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD fellow

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 19, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

DK (1)