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Completed

NCT Number: NCT01945931

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

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.

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Key information

Conditions

Maternal Mortality Death Female Urogenital Diseases and Pregnancy Complications Maternal Death Parental Death Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Perinatal Mortality Pregnancy Complications Urogenital Diseases

Age range

10 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

København V, 1658, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women in active labor

Exclusion criteria

  • None

Treatment and study plan

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.

Primary outcomes

  1. Perinatal mortality (stillbirth and early neonatal death)

    Time frame: Participants will be followed from delivery until 7 days postpartum

  2. Postpartum haemorrhage

    Time frame: Participants will be followed from delivery until two hours postpartum

Secondary outcomes

  1. 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

  2. Health workers clinical performance in management of neonatal resuscitation

    Time frame: 0, 6 and 12 months

  3. 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

  4. Health workers knowledge of management of neonatal resuscitation

    Time frame: 0, 6 and 12 months

Other outcomes

  1. Mortality stratified according to gestational age and birth weight

    Time frame: Participants will be followed from delivery until 7 days postpartum

  2. Use of the Safe Delivery application (when, how much and by whom)

    Time frame: Participants will be followed during the 12 months trial period

  3. Process indicators of services provided

    Time frame: Participants will be followed from delivery until 7 days postpartum

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Sep 19, 2013
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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