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Improving the diagnosis of malaria in pregnant women

PHASE 3 EVALUATION OF AN INNOVATIVE SIMPLE MOLECULAR TEST FOR THE DIAGNOSIS OF MALARIA AND FOLLOW-UP OF TREATMENT EFFICACY IN PREGNANT WOMEN IN SUB-SAHARAN AFRICA

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
PACTR
Registry ID
PACTR202203780981413
Enrollment
1016
Registered
2022-03-17
Start date
2022-01-03
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Malaria

Interventions

Sponsors

Academic Medical Centre at the University of Amsterdam
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Gestation =16 weeks and <37 weeks as assessed by ultrasound when possible, uterine height or late menstrual period; 2. Age: =18 years (DRC) or Age: =15 years (Burkina Faso); 3. Residence within the health facility catchment area; 4. Ability to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Not meeting the above criteria 2. Known history of allergy to SP or to an ACT 3. An ongoing antibioprophylaxis with cotrimoxazole, 4. Current issue requiring hospital admission (including severe malaria as defined by WHO) 5. Pregnancy at high risk.

Design outcomes

Primary

MeasureTime frame
sensitivity, specificity, negative and positive predictive values of mini-dbPCR-NALFIA test to detect malaria infection in pregnant women compared to routine diagnostic procedures in place

Secondary

MeasureTime frame
To determine the utility of the mini-dbPCR-NALFIA test in monitoring treatment efficacy, parasite clearance will be assessed by mini-dbPCR-NALFIA and compared with qPCR Burkina Faso;sensitivity, specificity, negative and positive predictive values of mini-dbPCR-NALFIA test compared to ultra sensitive RDT for the diagnosis of malaria in pregnant women DRC

Countries

Burkina Faso, Democratic Republic of the Congo

Contacts

Public ContactPetra Mens

Senior scientist Malaria

p.f.mens@amsterdamumc.nl+3120655454

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026