Community-based scheduled screening and treatment of malaria in pregnancy for improved maternal and infant health
- Conditions
- MalariaInfections and InfestationsUnspecified malaria
- Registration Number
- ISRCTN37259296
- Lead Sponsor
- Royal Tropical Institute (KIT)
- Brief Summary
1. 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25169073 2. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30384846 3. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/29961848
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 5400
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
1. A history of sensitivity to sulphonamides
2. Already participating in another research study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method <br> 1. Maternal anaemia<br> 2. Malaria peripheral infection<br> 3. Low birth weight - newborns will be weighed as soon as possible after birth and gestational age will be established by the Ballard Score<br> 4. IPTp-SP coverage by cluster (village/community), and selection of SP resistance markers<br> 5. Antenatal clinic attendance and coverage of intermittent preventive treatment during pregnancy.<br>