Postpartum HemorrhageNCT02185625
Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana
A study testing Safe Delivery smartphone application in people with Postpartum Hemorrhage and Delivery, Obstetric, run by University of Aarhus at 15 sites in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Hemorrhage, Delivery, Obstetric, Stillbirth
- What is being tested?
- Safe Delivery smartphone application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,773 participants
- Where
- 15 sitesGhana
- Study dates
- Jul 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
None listed.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Ghana15 sites
Achimota Hospital
Accra
Ashaiman Polyclinic
Accra
Ga South Municipal Hospital
Accra
Ga West Municipal Hospital
Accra
Keneshi Polyclinic
Accra
La General Hospital
Accra
Lekma Hospital
Accra
Maamobi General Hospital
Accra
Madina Polyclinic
Accra
Mamprobi Polyclinic
Accra
Ridge Hospital
Accra
Shai Osu Doku District Hospital
Accra
Tema General Hospital
Accra
Tema Polyclinic
Accra
Usher Poly (James Town Maternity Home)
Accra
About this study
Official title: 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.
- Being tested
- Safe Delivery smartphone application
- Medical subject headings
- Postpartum Hemorrhage, Stillbirth, Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe Delivery smartphone applicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Safe Delivery smartphone application | Experimental | Not described Receives: Device: Safe Delivery smartphone application |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Hemorrhage.
Postpartum Hemorrhage is defined as blood loss greater than 500 ml from bleeding associated with childbirth within first 2 hours postpartum.
Measured: Measurements 2 hours after delivery.
Secondary outcomes (5)
Blood loss
Amount of blood loss (ml) from bleeding associated with childbirth within first 2 hours postpartum.
Measured: Measurements 2 hours after delivery.
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.
Measured: At baseline and 2 months after randomization.
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.
Measured: At baseline and 2 months after randomization.
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.
Measured: At delivery.
Neonatal mortality 7 days postpartum.
A baby born alive with a birth weight above 1000 g who dies within 7 days postpartum.
Measured: Within 7 days postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,773 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University of Ghana, Maternity Foundation, Augustinus Fonden, Lundbeck Foundation, Edith and Godtfred Kirk Christiansen Foundation, Aase and Ejnar Danielsens Foundation
- Responsible party
- Sponsor
- Investigators
- Christina MB Nielsen, BSc, MPH, Principal investigator, Department of Public Health, Aarhus University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185625
- Sponsor's protocol ID
- AU201407
- Other IDs
- AU201407
- Status last verified
- Jul 2015
- First submitted
- 1 Jul 2014
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Adverse Pregnancy Outcomes With a Smartphone Application in Ghana: a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02185625
- Acronym / sponsor ID
- AU201407
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,773 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Copenhagen, University of Ghana, Maternity Foundation, Augustinus Fonden, Lundbeck Foundation, Edith and Godtfred Kirk Christiansen Foundation, Aase and Ejnar Danielsens Foundation
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safe Delivery smartphone application | Experimental | Device: Safe Delivery smartphone application |
| Control | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe Delivery smartphone applicationThe 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. | Device | Safe Delivery smartphone application |
Primary outcome
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.
5 secondary outcomes
Blood loss
Time frame: Measurements 2 hours after delivery.
Key feature questionnaire (KFQ).
Time frame: At baseline and 2 months after randomization.
Objective structured assessment of technical skill (OSATS).
Time frame: At baseline and 2 months after randomization.
Fresh stillbirth
Time frame: At delivery.
Neonatal mortality 7 days postpartum.
Time frame: Within 7 days postpartum.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina MB Nielsen, BSc, MPH principal investigator
Department of Public Health, Aarhus University, Denmark
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe Delivery smartphone application in people with Postpartum Hemorrhage and Delivery, Obstetric, run by University of Aarhus at 15 sites in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Hemorrhage. (time frame: Measurements 2 hours after delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.