Malaria Infections and Infestations Unspecified malaria
Conditions
Interventions
A two-armed cluster randomised controlled trial in which communities/villages will be randomised to receive either the intervention 'intermittent preventive treatment in pregnancy' plus 'community-bas
Sponsors
Royal Tropical Institute (KIT)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Residence in the study area and intention to stay in the area for the duration of the pregnancy and for delivery. 2. Aged at least 16 years (pregnant adolescents younger than 16 years will be considered only if they are accompanied by a responsible adult [in the Gambia] or married [considered an adult by marriage in Burkina Faso and Benin]) 3. Willing to provide biological samples as and when required during the study period (blood and placental biopsy) 4. Informed consent
Exclusion criteria
Exclusion criteria: 1. A history of sensitivity to sulphonamides 2. Already participating in another research study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Placental malaria, at delivery a placental biopsy will be obtained that will be transferred to the Medical Research Council unit in the Gambia for histological analysis (presence of parasites and pigment deposition). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maternal anaemia 2. Malaria peripheral infection 3. Low birth weight - newborns will be weighed as soon as possible after birth and gestational age will be established by the Ballard Score 4. IPTp-SP coverage by cluster (village/community), and selection of SP resistance markers 5. Antenatal clinic attendance and coverage of intermittent preventive treatment during pregnancy. | — |
Countries
Benin, Burkina Faso, Gambia
Outcome results
None listed