A Phase 4 interventional study of ASAQ in Malaria, sponsored by Centre Muraz. Completed at 1 site in Burkina Faso. Open to female participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-07-31.
Sponsored by Centre Muraz · Phase 4, Interventional, and Prevention
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.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 5,254 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Centre Muraz is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Drug: ASAQ
At ANC and labor wards for women in the control area, there will be no change from routine approaches.
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.
Also known as: Coarsucam, ASAQ Winthrop
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 )
Time frame: 9 months
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)
Time frame: 9 months
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),
Time frame: 9 months
Low Birth Weight
Low Birth Weight (defined as \<2500g)
Time frame: 9 months
Stillbirth
Stillbirth (defined as dead birth after 28 weeks of gestation)
Time frame: 28 weeks of gestation
Perinatal and early neonatal deaths
Perinatal and early neonatal deaths (i.e. death within 7 days of birth)
Time frame: 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.
Time frame: 9 months
Maternal death
Maternal death (death within 42 days of delivery, regardless of cause)
Time frame: 42 days post delivery
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Centre Muraz