Malaria
Conditions
Keywords
Malria diagnosis, Malaria prevention in pregnancy, ANC services improvement
Brief summary
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.
Detailed description
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.
Interventions
DRUGASAQ
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.
Sponsors
World Health Organization
Centre Muraz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Located in the geographical location of Dafra & Do district * Have a minimum attendance of 200 pregnant women per year
Exclusion criteria
* other public health facilities, private clinics and Dafra District Hospital will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Placental malaria at delivery | 9 months | 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 ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of women with peripheral positive malaria infection at delivery | 9 months | The proportion of women with peripheral positive malaria infection at delivery (defined via detection of asexual stages of P. f alciparum by microscopy) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stillbirth | 28 weeks of gestation | Stillbirth (defined as dead birth after 28 weeks of gestation) |
| Perinatal and early neonatal deaths | 7 days post delivery | Perinatal and early neonatal deaths (i.e. death within 7 days of birth) |
| The proportion of women with severe anaemia in women at delivery | 9 months | The proportion of women with severe anaemia in women at delivery (severe anaemia defined as Hg \<8 g/dL), |
| Maternal death | 42 days post delivery | Maternal death (death within 42 days of delivery, regardless of cause) |
| External/observable birth defects | 9 months | Presence of external/observable birth defects in neonates identified at birth or as soon as possible thereafter. |
| Low Birth Weight | 9 months | Low Birth Weight (defined as \<2500g) |
Countries
Burkina Faso
Outcome results
None listed