Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana

May 18, 2016 updated by: University of Aarhus

Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana: a Cluster Randomized Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3773

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
      • Accra, Ghana
        • Ridge Hospital
      • Accra, Ghana
        • Tema General Hospital
      • Accra, Ghana
        • LA General Hospital
      • Accra, Ghana
        • Achimota Hospital
      • Accra, Ghana
        • Ashaiman Polyclinic
      • Accra, Ghana
        • Ga South Municipal Hospital
      • Accra, Ghana
        • Ga West Municipal Hospital
      • Accra, Ghana
        • Keneshi Polyclinic
      • Accra, Ghana
        • Lekma Hospital
      • Accra, Ghana
        • Maamobi General Hospital
      • Accra, Ghana
        • Madina Polyclinic
      • Accra, Ghana
        • Mamprobi Polyclinic
      • Accra, Ghana
        • Shai Osu Doku District Hospital
      • Accra, Ghana
        • Tema Polyclinic
      • Accra, Ghana
        • Usher Poly (James Town Maternity Home)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria for Hospitals:

  • 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.

Inclusion criteria for midwives:

  • 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.

Inclusion criteria for women in labor:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Experimental: Safe Delivery smartphone application
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postpartum Hemorrhage.
Time Frame: Measurements 2 hours after delivery.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: Measurements 2 hours after delivery.
Amount of blood loss (ml) from bleeding associated with childbirth within first 2 hours postpartum.
Measurements 2 hours after delivery.
Key feature questionnaire (KFQ).
Time Frame: At baseline and 2 months after randomization.
The KFQ questionnaire measures midwives' knowledge in relation to 1) active management of the third stage of labour, 2) treatment of postpartum hemorrhage, 3) manual removal of placenta, and 4) neonatal resuscitation. The midwives' performance will be scored by research assistants by use of the KFQ tool.
At baseline and 2 months after randomization.
Objective structured assessment of technical skill (OSATS).
Time Frame: At baseline and 2 months after randomization.
The OSATS tool measures midwives' skills in relation to 1) active management of the third stage of labour, 2) treatment of postpartum hemorrhage, 3) manual removal of placenta, and 4) neonatal resuscitation. The midwives' performance will be scored by research assistants by use of the OSATS tool.
At baseline and 2 months after randomization.
Fresh stillbirth
Time Frame: At delivery.
Delivery of a fetus with a birth weight above 1,000 g birth weight who at birth has no signs of life (breathing, crying or movement) with intact skin.
At delivery.
Neonatal mortality 7 days postpartum.
Time Frame: Within 7 days postpartum.
A baby born alive with a birth weight above 1000 g who dies within 7 days postpartum.
Within 7 days postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen
University of Ghana
Lundbeck Foundation
Augustinus Fonden
Aase and Ejnar Danielsens Foundation
Maternity Foundation
Edith and Godtfred Kirk Christiansen Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christina MB Nielsen, BSc, MPH, Department of Public Health, Aarhus University, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AU201407 (Other Identifier: Aarhus University, Department of Public Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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