Pregnancy RelatedNCT06225739
Evaluation of Electronic Pregnancy Registers and Mobile Applications for Monitoring Pregnancy Outcomes ( EVAPREAP )
An observational study of Pregnancy Related, run by European Vaccine Initiative at 4 sites in 4 countries.
Trial summary
Monitoring pregnancy outcomes during pregnancy is very important in assessing the effectiveness of interventions. This study aims to create pregnancy registers and evaluate pregnancy mobile applications as a potential tool for monitoring pregnancy outcomes in future placental malaria (PM) vaccine trials, as well as… Read more about this study
- Who is it for?
- Ages 15 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Electronic pregnancy register and In-depth interviews and focus group discussions
- How many people
- 2,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Oct 2023to 30 Apr 2025
- How long will I take part?
- 9 Months
- Phase
- Observational
- 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 15 to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Phase 1 study population will include pregnant women of all ages attending antenatal care (ANC) facility. Phase 2 study population will include pregnant women aged 15-49 years attending ANC facility and health workers who provide healthcare services to pregnant women at ANC clinics or Maternity ward
Who may be able to join
- Pregnant women attending ANC facility in the study area
- Pregnant women whose ANC information can be accessed at the ANC facility
- Health workers providing care to pregnant women at ANC or Maternity facilities
Who cannot join
- Pregnant women attending ANC outside the study area
- Pregnant women whose ANC information cannot be accessed at the ANC facility
- Pregnant women unwilling or unable to provide informed consent
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Burkina Faso1 site
Groupe de Recherche Action en Santé (GRAS)
Ouagadougou
About this study
Official title: Evaluation of Electronic Pregnancy Registers and Mobile Applications as a Potential Tool for Promoting Antenatal Care and Monitoring Pregnancy Outcomes
Monitoring pregnancy outcomes during pregnancy is very important in assessing the effectiveness of interventions. This study aims to create pregnancy registers and evaluate pregnancy mobile applications as a potential tool for monitoring pregnancy outcomes in future placental malaria (PM) vaccine trials, as well as for the implementation of any other intervention in this target group.
Read the detailed description
Background: Malaria during pregnancy remains a major public health problem. A consortium from Africa and Europe is further advancing the clinical development of two PM vaccine candidates (PAMVAC-cVLP and PRIMVAC). These vaccines have previously been shown to be safe, well-tolerated and able to induce a strong and functional immune response. Monitoring pregnancy outcomes during pregnancy is very important in assessing the effectiveness of interventions against PM. The increased availability of mobile phones makes them a potential tool for improving quality of care for pregnant women, accurately collecting and reporting pregnancy outcomes in identified cohorts of pregnant women. Data on the feasibility and acceptability of the mobile applications for tracking pregnancy outcomes in the areas targeted for clinical testing of candidate PM vaccines is however limited. This study will explore the creation of electronic pregnancy registers and evaluate pregnancy mobile applications as a potential tool for monitoring pregnancy outcomes in future PM vaccine trials, as well as for the implementation of other future interventions in Ghana, Burkina Faso, Benin and Malawi.
Overall aim: To evaluate the feasibility and acceptability of open-source mobile applications in tracking pregnancy outcomes among pregnant women in sub- Saharan Africa.
Methods: The study will be carried out in two phases. The first phase will involve the mapping of health application tools, and the selection of one of the tools for the registration of pregnancies at each of the participating sites. The evaluation process will involve a two-level test namely alpha and beta. Prior to the selection of the electronic tool, the team will define the data characteristics and requirements of the pregnancy register. This will be followed by a description of the process flow and the expected functionality of the pregnancy register including visualization and reporting of outcomes of interest. After this, specifications of the interface technologies, the database technologies, and the network requirements will be determined. Each site will create a pregnancy register using REDCap. The second phase will involve the assessment of the feasibility and acceptability of mobile application. At the evaluation phase, qualitative methods will be used to assess the feasibility and acceptability of using the selected mobile application for tracking pregnancy outcomes. The selected app will be tested by pregnant women. In-depth interviews (IDIs) and focus group discussions (FGDs) will be used to explore the perceptions of pregnant women and health workers on the feasibility, usability, and acceptability of open-source mobile applications for tracking pregnancy outcomes among pregnant women. Pregnant women from rural and urban parts of the study areas who will be able to use the electronic application and are willing to participate in the interviews will be purposively selected from the pregnancy register, and health workers sampled from the health facilities.
Expected outcome: The assessment of mobile applications for monitoring pregnancy outcomes and development of pregnancy registers will build the base for future PM vaccine trials and any other interventions tackling PM. If acceptability and feasibility is demonstrated, mobile applications could be linked to other tools that will provide support to front line health care workers and patients to ensure uptake and continued access to essential maternal and neonatal care services through responsive customized needs of patients in view of routine care packages.
- Conditions
- Pregnancy Related
- Being tested
- Electronic pregnancy register, In-depth interviews and focus group discussions
- Keywords
- Pregnancy register, Mobile application, Pregnancy outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic pregnancy registerOther
Electronic pregnancy register will be created based on local ANC register to monitor pregnancy outcomes across all sites. Pregnant women of all ages attending antenatal care (ANC) facility will be registered
In-depth interviews and focus group discussionsOther
In-depth interviews (IDIs) and focus group discussions (FGDs) will be used to assess the user experience and the perceptions of pregnant women and health workers on the feasibility, usability, and acceptability of open-source mobile applications for tracking pregnancy outcomes
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Not described Receives: Other: Electronic pregnancy register; Other: In-depth interviews and focus group discussions | |
| Health care providers | In-depth interviews (IDIs) and focus group discussions (FGDs) will be used to assess the user experience and the perceptions of pregnant women and health workers on the feasibility, usability, and acceptability of open-source mobile applications for tracking pregnancy outcomes Receives: Other: In-depth interviews and focus group discussions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of mobile application for registration of pregnant women and tracking pregnancy outcomes
Assess whether an open-source mobile applications is easy and convenient to use accounting for advantages and disadvantages to guide integrating the App into routine workflow via qualitative methods: In-depth interviews (IDIs) and focus group discussions (FGDs)
Measured: 9 months
Usability of mobile application for registration of pregnant women and tracking pregnancy outcomes
Assess whether open-source mobile applications could be used by pregnant women and health workers to adequately record, track, and summarize data, including whether it functioned in a way that enhanced productivity or led to unproductive tasks due to errors. The assessment will be done using qualitative methods: In-depth interviews (IDIs) and focus group discussions (FGDs)
Measured: 9 months
Acceptability of mobile application for registration of pregnant women and tracking pregnancy outcomes
Acceptability will be defined as pregnant women and health workers and other stakeholders found the Client Data App acceptability, including its interface and navigation features. The assessment will be done using qualitative methods: In-depth interviews (IDIs) and focus group discussions (FGDs)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Oct 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- European Vaccine Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- Kintampo Health Research Centre, Ghana, Fondation pour la Recherche Scientifique, Benin, Groupe de Recherche Action en Sante, Malawi University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Kwaku Poku Asante, MD, PhD, Principal investigator, Kintampo Health Research Centre, Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225739
- Sponsor's protocol ID
- EVAPREAP-01
- Status last verified
- Aug 2025
- First submitted
- 17 Jan 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Electronic Pregnancy Registers and Mobile Applications as a Potential Tool for Promoting Antenatal Care and Monitoring Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT06225739
- Acronym / sponsor ID
- EVAPREAP-01
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy register, Mobile application, Pregnancy outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- European Vaccine InitiativeUniversity, hospital or other
- Collaborators
- Kintampo Health Research Centre, Ghana, Fondation pour la Recherche Scientifique, Benin, Groupe de Recherche Action en Sante, Malawi University of Science and Technology
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 26 Jan 2024 (actual)
- 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.
Monitoring pregnancy outcomes during pregnancy is very important in assessing the effectiveness of interventions. This study aims to create pregnancy registers and evaluate pregnancy mobile applications as a potential tool for monitoring pregnancy outcomes in future placental malaria (PM) vaccine trials, as well as for the implementation of any other intervention in this target group.
Detailed description
Background: Malaria during pregnancy remains a major public health problem. A consortium from Africa and Europe is further advancing the clinical development of two PM vaccine candidates (PAMVAC-cVLP and PRIMVAC). These vaccines have previously been shown to be safe, well-tolerated and able to induce a strong and functional immune response. Monitoring pregnancy outcomes during pregnancy is very important in assessing the effectiveness of interventions against PM. The increased availability of mobile phones makes them a potential tool for improving quality of care for pregnant women, accurately collecting and reporting pregnancy outcomes in identified cohorts of pregnant women. Data on the feasibility and acceptability of the mobile applications for tracking pregnancy outcomes in the areas targeted for clinical testing of candidate PM vaccines is however limited. This study will explore the creation of electronic pregnancy registers and evaluate pregnancy mobile applications as a potential tool for monitoring pregnancy outcomes in future PM vaccine trials, as well as for the implementation of other future interventions in Ghana, Burkina Faso, Benin and Malawi.
Overall aim: To evaluate the feasibility and acceptability of open-source mobile applications in tracking pregnancy outcomes among pregnant women in sub- Saharan Africa.
Methods: The study will be carried out in two phases. The first phase will involve the mapping of health application tools, and the selection of one of the tools for the registration of pregnancies at each of the participating sites. The evaluation process will involve a two-level test namely alpha and beta. Prior to the selection of the electronic tool, the team will define the data characteristics and requirements of the pregnancy register. This will be followed by a description of the process flow and the expected functionality of the pregnancy register including visualization and reporting of outcomes of interest. After this, specifications of the interface technologies, the database technologies, and the network requirements will be determined. Each site will create a pregnancy register using REDCap. The second phase will involve the assessment of the feasibility and acceptability of mobile application. At the evaluation phase, qualitative methods will be used to assess the feasibility and acceptability of using the selected mobile application for tracking pregnancy outcomes. The selected app will be tested by pregnant women. In-depth interviews (IDIs) and focus group discussions (FGDs) will be used to explore the perceptions of pregnant women and health workers on the feasibility, usability, and acceptability of open-source mobile applications for tracking pregnancy outcomes among pregnant women. Pregnant women from rural and urban parts of the study areas who will be able to use the electronic application and are willing to participate in the interviews will be purposively selected from the pregnancy register, and health workers sampled from the health facilities.
Expected outcome: The assessment of mobile applications for monitoring pregnancy outcomes and development of pregnancy registers will build the base for future PM vaccine trials and any other interventions tackling PM. If acceptability and feasibility is demonstrated, mobile applications could be linked to other tools that will provide support to front line health care workers and patients to ensure uptake and continued access to essential maternal and neonatal care services through responsive customized needs of patients in view of routine care packages.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: Electronic pregnancy register, Other: In-depth interviews and focus group discussions |
| Health care providers | – | Other: In-depth interviews and focus group discussionsIn-depth interviews (IDIs) and focus group discussions (FGDs) will be used to assess the user experience and the perceptions of pregnant women and health workers on the feasibility, usability, and acceptability of open-source mobile applications for tracking pregnancy outcomes |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Phase 1 study population will include pregnant women of all ages attending antenatal care (ANC) facility. Phase 2 study population will include pregnant women aged 15-49 years attending ANC facility and health workers who provide healthcare services to pregnant women at ANC clinics or Maternity ward
Key inclusion criteria (3 listed)
- Pregnant women attending ANC facility in the study area
- Pregnant women whose ANC information can be accessed at the ANC facility
- Health workers providing care to pregnant women at ANC or Maternity facilities
Key exclusion criteria (3 listed)
- Pregnant women attending ANC outside the study area
- Pregnant women whose ANC information cannot be accessed at the ANC facility
- Pregnant women unwilling or unable to provide informed consent
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 |
|---|---|---|
| Electronic pregnancy registerElectronic pregnancy register will be created based on local ANC register to monitor pregnancy outcomes across all sites. Pregnant women of all ages attending antenatal care (ANC) facility will be registered | Other | Pregnant women |
| In-depth interviews and focus group discussionsIn-depth interviews (IDIs) and focus group discussions (FGDs) will be used to assess the user experience and the perceptions of pregnant women and health workers on the feasibility, usability, and acceptability of open-source mobile applications for tracking pregnancy outcomes | Other | Health care providers, Pregnant women |
Primary outcome
Feasibility of mobile application for registration of pregnant women and tracking pregnancy outcomes
Time frame: 9 months
Assess whether an open-source mobile applications is easy and convenient to use accounting for advantages and disadvantages to guide integrating the App into routine workflow via qualitative methods: In-depth interviews (IDIs) and focus group discussions (FGDs)
Usability of mobile application for registration of pregnant women and tracking pregnancy outcomes
Time frame: 9 months
Assess whether open-source mobile applications could be used by pregnant women and health workers to adequately record, track, and summarize data, including whether it functioned in a way that enhanced productivity or led to unproductive tasks due to errors. The assessment will be done using qualitative methods: In-depth interviews (IDIs) and focus group discussions (FGDs)
Acceptability of mobile application for registration of pregnant women and tracking pregnancy outcomes
Time frame: 9 months
Acceptability will be defined as pregnant women and health workers and other stakeholders found the Client Data App acceptability, including its interface and navigation features. The assessment will be done using qualitative methods: In-depth interviews (IDIs) and focus group discussions (FGDs)
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 5 Aug 2025.
- Related InfoLink provided by the sponsor.
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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.
Kwaku Poku Asante, MD, PhD principal investigator
Kintampo Health Research Centre, Ghana
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by European Vaccine Initiative at 4 sites in 4 countries.
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 3 inclusion and 3 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 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Benin, Burkina Faso, Ghana, Malawi. 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?
Feasibility of mobile application for registration of pregnant women and tracking pregnancy outcomes (time frame: 9 months). The study lists 3 primary outcomes in all. 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 5 Aug 2025.