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PROMISE (Placental malaria: Recognition Of host potential biomarkers associated with the dISEase)

Placental malaria: identification of host potential biomarkers associated with the disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202407739257214
Enrollment
100
Registered
2024-07-29
Start date
2024-09-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

PM Positive
PM Negative

Sponsors

Clinical Research Unit of Nanoro
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Only samples that meet the following criteria will be included in the current study: - The donor pregnant woman signed an informed consent authorizing the further use of their samples in studies of malaria and other infectious diseases. - Availability of subsequent samples from the same individual at Days 0, 28, 63;

Exclusion criteria

Exclusion criteria: - Absence of clinical data related to the samples; - Absence of placenta biopsy for analysis.

Design outcomes

Primary

MeasureTime frame
Diagnostic Accuracy: - Sensitivity and Specificity: Assess the sensitivity, specificity, and predictive value of IL-10, sTNF-RII, antibodies to DBL5, C5a, and VEGF in detecting PM using plasma samples. - Biomarker Performance Dataset: Compile data on biomarker performance to identify the most accurate candidates for inclusion in a future diagnostic platform.

Secondary

MeasureTime frame
Biomarker Variability: - Stage of Pregnancy: Analyze how biomarker levels vary across different stages of pregnancy to ensure they consistently detect PM. - Anti-malarial Treatments: Conduct a stratified analysis to observe biomarker variations across different anti-malarial treatments.;Integration with Intervention Strategies: - Enhance Effectiveness: Evaluate how the validated biomarkers can be incorporated with existing intervention strategies to improve their overall effectiveness in combating PM.;Conceptual Framework: - Diagnostic Tool Development: Create a prototype of a user-friendly, accurate, and feasible diagnostic tool suitable for resource-limited settings using the most promising biomarkers.;Temporal Dynamics: - Biomarker Levels: Track changes in biomarker levels at specific time points (days 0, 28, and 63) during pregnancy to understand their temporal dynamics in relation to PM.

Countries

Burkina Faso

Contacts

Public ContactOusmane Traore

Researcher

ousmane.traore@crun.bf+22674141422

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026