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| Name | Class |
|---|---|
| World Health Organization | OTHER |
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The program's overall objective is to assess the impact of a package of interventions aimed at reducing malaria-related mortality and morbidity in pregnant women and newborns by ensuring access to a package of interventions designed to optimise the detection and treatment of malaria during pregnancy as well as improving the early detection and treatment of malaria during the third trimester.
This is a cluster-randomised study in which the health facility is the unit of randomisation. 16 health facilities will be randomised to intervention and control. At the community level women will be encouraged to access ANC early in the pregnancy, attend follow-up antenatal visits throughout the pregnancy and deliver at the facility. The current recommended standard of care will be provided to all women attending antenatal and obstetric care. In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy (> 28 weeks of pregnancy), women will be systematically evaluated with selected diagnostic test for whether they have malaria parasites and treated effectively. Skilled birth attendants at the facility will be trained in emergency obstetric and neonatal care and the assessment of neonates for danger signs, low birth weight and external/observable birth defects. In the control area, women will be provided with standard practice of care. In both areas, women will be diagnosed and treated at delivery if they are positive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASAQ | Experimental | In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy women will be systematically evaluated with RDT for whether they have malaria parasites and treated effectively. |
|
| SP | No Intervention | At ANC and labor wards for women in the control area, there will be no change from routine approaches. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASAQ | Drug | In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy (> 28 weeks of pregnancy), women will be systematically evaluated with malaria RDT for whether they have malaria parasites and treated effectively with ASAQ. |
| Measure | Description | Time Frame |
|---|---|---|
| Placental malaria at delivery | The main outcome variable of interest will be the proportion of women in each group with placental malaria at delivery (defined as placental biopsies positive for P. falciparum ) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of women with peripheral positive malaria infection at delivery | The proportion of women with peripheral positive malaria infection at delivery (defined via detection of asexual stages of P. f alciparum by microscopy) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of women with severe anaemia in women at delivery | The proportion of women with severe anaemia in women at delivery (severe anaemia defined as Hg <8 g/dL), | 9 months |
| Low Birth Weight | Low Birth Weight (defined as <2500g) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Halidou Tinto, PharmD, PhD | centre muraz - irss | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dafra & Do districts | Bobo-Dioulasso | Hauts Bassins-houet | 01 | Burkina Faso |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| 9 months |
| Stillbirth | Stillbirth (defined as dead birth after 28 weeks of gestation) | 28 weeks of gestation |
| Perinatal and early neonatal deaths | Perinatal and early neonatal deaths (i.e. death within 7 days of birth) | 7 days post delivery |
| External/observable birth defects | Presence of external/observable birth defects in neonates identified at birth or as soon as possible thereafter. | 9 months |
| Maternal death | Maternal death (death within 42 days of delivery, regardless of cause) | 42 days post delivery |
| D000079426 |
| Vector Borne Diseases |