Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana

NCT02185625 | Completed

• 1 other identifier: AU201407
• Study Type: interventional
• Target: 3,773
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to determine whether use of the Safe Delivery smartphone application by midwives can reduce excess blood loss from bleeding, and infant death during childbirth in Ghanaian women. Moreover, it will be investigated whether the Safe Delivery application can increase midwives' knowledge and skills in managing childbirth. Fifteen hospitals in Greater Accra, Ghana, will be cluster randomized to either use the Safe Delivery application (intervention), or to no intervention (control). In the intervention hospitals, midwives will be educated in the use of Safe Delivery. Pregnant women will be enrolled at delivery and followed until 7 days postpartum. Data collection will begin July 2014 and is expected to be finished by October 2014.

Conditions

Postpartum Hemorrhage; Delivery, Obstetric; Stillbirth; Infant Mortality; Midwifery

Outcome Measures

Primary Outcomes (1)

• Postpartum Hemorrhage.

  Postpartum Hemorrhage is defined as blood loss greater than 500 ml from bleeding associated with childbirth within first 2 hours postpartum.

  Measurements 2 hours after delivery.

Secondary Outcomes (5)

• Blood loss

  Measurements 2 hours after delivery.

• Key feature questionnaire (KFQ).

  At baseline and 2 months after randomization.

• Objective structured assessment of technical skill (OSATS).

  At baseline and 2 months after randomization.

• Fresh stillbirth

  At delivery.

• Neonatal mortality 7 days postpartum.

  Within 7 days postpartum.

Study Arms (2)

Safe Delivery smartphone application

EXPERIMENTAL

Device: Safe Delivery smartphone application

Control

NO INTERVENTION

Interventions

Safe Delivery smartphone application DEVICE

The intervention is the use of a smartphone application called Safe Delivery, designed by University of Copenhagen, Denmark and Maternity Foundation Denmark. The application contains animated videos aimed to train midwives in the prevention and management of postpartum hemorrhage and the treatment of neonatal resuscitation. The instructions in the videos are based on WHO recommendations, and the application is designed to be an on-going tool for midwives, so that they can drill themselves in the emergencies of postpartum hemorrhage and neonatal resuscitation.

Safe Delivery smartphone application

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Located in the region of Greater Accra.
• The hospital should have at least 10 midwives employed.
• The patient flow for each midwife should be at least 10 deliveries per month.
• The annual average number of deliveries should be at least 1,200.
• Should have no leave or vacation from June 17th to September 17th 2014.
• Should have a full time employment at the delivery ward (conducting deliveries 100% of the work time).
• Should be willing and available to participate in an information meeting at the hospital where the balloting among eligible midwives will take place.
• Should give an informed consent to participate in the study.
• Should be willing and available to participate in a workshop July 14th 2014 (this is the day of randomization, and intervention midwives will receive smartphone training).
• Should be willing and available to participate in a workshop September 17th 2014 (to complete an end of study questionnaire, the key feature questionnaire, and control midwives will receive smartphones).
• Should be proficient in English to understand the spoken instructions in the animated videos.
• Should be in active labor.
• Should give informed consent to participate in the study.
• Should give birth vaginally.
• The women in labor and their newborn children will be the primary observational units.

Sponsors & Collaborators

• University of Aarhus: lead
• University of Copenhagen: collaborator
• University of Ghana: collaborator
• Maternity Foundation: collaborator
• Augustinus Fonden: collaborator
• Lundbeck Foundation: collaborator
• Edith and Godtfred Kirk Christiansen Foundation: collaborator
• Aase and Ejnar Danielsens Foundation: collaborator

Study Sites (15)

Achimota Hospital

Accra, Ghana

Location

Ashaiman Polyclinic

Accra, Ghana

Location

Ga South Municipal Hospital

Accra, Ghana

Location

Ga West Municipal Hospital

Accra, Ghana

Location

Keneshi Polyclinic

Accra, Ghana

Location

La General Hospital

Accra, Ghana

Location

Lekma Hospital

Accra, Ghana

Location

Maamobi General Hospital

Accra, Ghana

Location

Madina Polyclinic

Accra, Ghana

Location

Mamprobi Polyclinic

Accra, Ghana

Location

Ridge Hospital

Accra, Ghana

Location

Shai Osu Doku District Hospital

Accra, Ghana

Location

Tema General Hospital

Accra, Ghana

Location

Tema Polyclinic

Accra, Ghana

Location

Usher Poly (James Town Maternity Home)

Accra, Ghana

Location

MeSH Terms

Conditions

Postpartum Hemorrhage; Stillbirth; Infant Death

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Death; Death

Study Officials

• Christina MB Nielsen, BSc, MPH

  Department of Public Health, Aarhus University, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 19, 2016

Record last verified: 2015-07

Locations

GH (15)