Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana

NCT ID: NCT02185625

Last Updated: 2016-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3773 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Hemorrhage Delivery, Obstetric Stillbirth Infant Mortality Midwifery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Safe Delivery smartphone application

Group Type EXPERIMENTAL

Safe Delivery smartphone application

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Safe Delivery smartphone application

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Copenhagen

OTHER

Sponsor Role collaborator

University of Ghana

OTHER

Sponsor Role collaborator

Maternity Foundation

UNKNOWN

Sponsor Role collaborator

Augustinus Fonden

OTHER

Sponsor Role collaborator

Lundbeck Foundation

OTHER

Sponsor Role collaborator

Edith and Godtfred Kirk Christiansen Foundation

UNKNOWN

Sponsor Role collaborator

Aase and Ejnar Danielsens Foundation

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christina MB Nielsen, BSc, MPH

Role: PRINCIPAL_INVESTIGATOR

Department of Public Health, Aarhus University, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Achimota Hospital

Accra, , Ghana

Site Status

Ashaiman Polyclinic

Accra, , Ghana

Site Status

Ga South Municipal Hospital

Accra, , Ghana

Site Status

Ga West Municipal Hospital

Accra, , Ghana

Site Status

Keneshi Polyclinic

Accra, , Ghana

Site Status

La General Hospital

Accra, , Ghana

Site Status

Lekma Hospital

Accra, , Ghana

Site Status

Maamobi General Hospital

Accra, , Ghana

Site Status

Madina Polyclinic

Accra, , Ghana

Site Status

Mamprobi Polyclinic

Accra, , Ghana

Site Status

Ridge Hospital

Accra, , Ghana

Site Status

Shai Osu Doku District Hospital

Accra, , Ghana

Site Status

Tema General Hospital

Accra, , Ghana

Site Status

Tema Polyclinic

Accra, , Ghana

Site Status

Usher Poly (James Town Maternity Home)

Accra, , Ghana

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ghana

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AU201407

Identifier Type: OTHER

Identifier Source: secondary_id

AU201407

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Birth Control to Improve Birth Spacing
NCT05240066 ACTIVE_NOT_RECRUITING
Reducing Adolescent Pregnancy
NCT04120376 COMPLETED NA