NCT06225739

Brief 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 for the implementation of any other intervention in this target group.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

August 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

January 17, 2024

Last Update Submit

August 4, 2025

Conditions

Pregnancy Related

Keywords

Pregnancy registerMobile applicationPregnancy outcome

Outcome Measures

Primary Outcomes (3)

  • 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)

    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)

    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)

    9 months

Study Arms (2)

Pregnant women

Other: Electronic pregnancy registerOther: 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

Other: In-depth interviews and focus group discussions

Interventions

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

Pregnant women
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

Health care providersPregnant women

Eligibility Criteria

Age15 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fondation pour la Recherche Scientifique (FORS)

Cotonou, Benin

Location

Groupe de Recherche Action en Santé (GRAS)

Ouagadougou, Burkina Faso

Location

Kintampo Health Research Centre (KHRC)

Kintampo, Ghana

Location

Malawi University of Science and Technology (MUST)

Mikolongwe, Malawi

Location

Related Links

Study Officials

  • Kwaku Poku Asante, MD, PhD

    Kintampo Health Research Centre, Ghana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2024

First Posted

January 26, 2024

Study Start

October 1, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

August 5, 2025

Record last verified: 2025-08

Locations

BU(1)BE(1)GH(1)MA(1)