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Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana

Primary Purpose

Postpartum Hemorrhage, Delivery, Obstetric, Stillbirth

Status
Completed
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
Safe Delivery smartphone application
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Safe Delivery smartphone application

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Blood loss
Amount of blood loss (ml) from bleeding associated with childbirth within first 2 hours postpartum.
Key feature questionnaire (KFQ).
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.
Objective structured assessment of technical skill (OSATS).
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.
Fresh stillbirth
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.
Neonatal mortality 7 days postpartum.
A baby born alive with a birth weight above 1000 g who dies within 7 days postpartum.

Full Information

First Posted
July 1, 2014
Last Updated
May 18, 2016
Sponsor
University of Aarhus
Collaborators
University of Copenhagen, University of Ghana, Maternity Foundation, Augustinus Fonden, Lundbeck Foundation, Edith and Godtfred Kirk Christiansen Foundation, Aase and Ejnar Danielsens Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02185625
Brief Title
Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana
Official Title
Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana: a Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
University of Copenhagen, University of Ghana, Maternity Foundation, Augustinus Fonden, Lundbeck Foundation, Edith and Godtfred Kirk Christiansen Foundation, Aase and Ejnar Danielsens Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Delivery, Obstetric, Stillbirth, Infant Mortality, Midwifery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3773 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safe Delivery smartphone application
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Safe Delivery smartphone application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postpartum Hemorrhage.
Description
Postpartum Hemorrhage is defined as blood loss greater than 500 ml from bleeding associated with childbirth within first 2 hours postpartum.
Time Frame
Measurements 2 hours after delivery.
Secondary Outcome Measure Information:
Title
Blood loss
Description
Amount of blood loss (ml) from bleeding associated with childbirth within first 2 hours postpartum.
Time Frame
Measurements 2 hours after delivery.
Title
Key feature questionnaire (KFQ).
Description
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.
Time Frame
At baseline and 2 months after randomization.
Title
Objective structured assessment of technical skill (OSATS).
Description
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.
Time Frame
At baseline and 2 months after randomization.
Title
Fresh stillbirth
Description
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.
Time Frame
At delivery.
Title
Neonatal mortality 7 days postpartum.
Description
A baby born alive with a birth weight above 1000 g who dies within 7 days postpartum.
Time Frame
Within 7 days postpartum.

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina MB Nielsen, BSc, MPH
Organizational Affiliation
Department of Public Health, Aarhus University, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Achimota Hospital
City
Accra
Country
Ghana
Facility Name
Ashaiman Polyclinic
City
Accra
Country
Ghana
Facility Name
Ga South Municipal Hospital
City
Accra
Country
Ghana
Facility Name
Ga West Municipal Hospital
City
Accra
Country
Ghana
Facility Name
Keneshi Polyclinic
City
Accra
Country
Ghana
Facility Name
La General Hospital
City
Accra
Country
Ghana
Facility Name
Lekma Hospital
City
Accra
Country
Ghana
Facility Name
Maamobi General Hospital
City
Accra
Country
Ghana
Facility Name
Madina Polyclinic
City
Accra
Country
Ghana
Facility Name
Mamprobi Polyclinic
City
Accra
Country
Ghana
Facility Name
Ridge Hospital
City
Accra
Country
Ghana
Facility Name
Shai Osu Doku District Hospital
City
Accra
Country
Ghana
Facility Name
Tema General Hospital
City
Accra
Country
Ghana
Facility Name
Tema Polyclinic
City
Accra
Country
Ghana
Facility Name
Usher Poly (James Town Maternity Home)
City
Accra
Country
Ghana

12. IPD Sharing Statement

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Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana

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