Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sulfadoxine pyrimethamine · 1 trial · 1 indication
Asymptomatic malaria is defined as the presence of Pf diagnosed by an us-RDT in the peripheral blood and a T°≤38°C
Symptomatic malaria is be defined as the presence of Pf diagnosed by an us-RDT in the peripheral blood and a T°≥38°C
Parasite density is assessed by the quantification of Pf parasites in the peripheral blood of asymptomatic/symptomatic women by a thin blood smear examined by standard malaria microscopy
Anemia is defined as a level of hemoglobin (Hb) \<10g/dl
Intrauterine death is defined to describe the death of the offspring in the uterus
Fetal morbidity is defined as any of the following: Preterm birth (birth before 37 weeks gestation) and low-birth-weight (birth weight under 2,500 grams)
The early neonatal mortality is defined as infant death at birth or within 7 days of life; And the neonatal mortality is defined as infant death within the first 28 days of life
| Arm | Type | Description |
|---|---|---|
| IPTp-SP | ACTIVE_COMPARATOR | The IPTp-SP group will be pregnant women who will receive the standard regimen recommended by the Malaria National Control Program (MNCP) at week 16, 28, 32 and 36 of their pregnancy |
| ISTp-US-Py | EXPERIMENTAL | The ISTp-US-Py group will comprise pregnant women who will be screened monthly from the beginning of the 2nd trimester with ultra-sensitive -RDT and who will be treated with Pyramax® if the test is positive |
| Name | Type | Description |
|---|---|---|
| Sulfadoxine pyrimethamine | DRUG | Intermittent Preventive Treatment in pregnant women with Sulfadoxine-Pyrimethamine |
| Pyramax | DRUG | Intermittent screening using ultra-sensitive malaria Rapid Diagnostic test and treatment using Pyronaridine - Artesunate (PYRAMAX®) |
Inclusion Criteria: 1. Gestation ≥16 weeks; 2. Age: ≥18 years; 3. Residence within the health facility catchment area; 4. Willing to adhere to study requirements and to deliver at the health facility. 5. Willing to provide written informed consent; if the woman is illiterate, she can choose an impa...