Community-based Screening and Treatment of Malaria in Pregnancy: a Cluster-randomized Trial
COSMIC
Community-based Scheduled Screening and Treatment of Malaria in Pregnancy for Improved Maternal and Infant Health: a Cluster-randomized Trial in The Gambia, Burkina Faso and Benin
2 other identifiers
interventional
4,265
3 countries
3
Brief Summary
Malaria is a common disease in Africa and a major health problem. Pregnant women are also at risk of malaria. Malaria in pregnancy is life threatening to both the mother and the baby she is carrying. It can result in the destruction of the mother's blood and in babies with a lower birth weight than normal, making them less healthy in their first years of life. These risks are even higher in women having their first pregnancy. When a woman is pregnant she should go to the Antenatal clinic (ANC) for care. Usually the ANC health staff gives the woman intermittent preventable treatment (IPTp-SP) against malaria. This drug helps protect the woman against getting malaria. Each pregnant woman should receive at least 2 doses of this drug during their pregnancy; thus, they should go the ANC at least 2 times during their pregnancy. However, many women still do not go often to the ANC for health care during their pregnancy. This study would like to see whether community health workers (CHW) can work with pregnant women to encourage them to attend ANC more often. Also, the CHW will test a pregnant woman every month for malaria with a rapid test. If a woman has malaria, the CHW will treat her in her home instead of the woman having to go a health clinic for treatment. The woman will be treated with a different drug than the drug that is given at the ANC visits. Our hypothesis is that this will improve the care and management of malaria during pregnancy and this will improve the health of women and their newborns. To see whether this strategy improved the health of women and their newborns, we will take a small piece of the placenta at delivery to test for malaria and we will weigh the baby. We will test this strategy in multiple communities. We will compare this to pregnant women in communities where this strategy was not followed, thus where pregnant women received standard care. Participants will be pregnant women. There are no direct benefits for participating in the study, except the outcome of our research question that is possible health benefits in the intervention group. The drugs involved are tested safe in pregnant women from second trimester on.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2013
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2013
CompletedFirst Posted
Study publicly available on registry
September 13, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedOctober 4, 2016
November 1, 2015
2.6 years
September 10, 2013
October 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Placental malaria
Placental malaria will be diagnosed by microscopy of placental biopsies and polymerase chain reaction (PCR) on placental blood.
After delivery
Secondary Outcomes (1)
Birth weight
After delivery
Other Outcomes (4)
antenatal care clinic attendance
Throughout inclusion (+/- 6 months)
Resistance to sulphadoxine-pyrimethamine (SP)
At delivery
Peripheral malaria infection
Throughout inclusion (+/- 6 months)
- +1 more other outcomes
Study Arms (2)
community based screening and treatment
ACTIVE COMPARATORCHWs will identify pregnant women in the village and encourage to go to the antenatal care clinic, furthermore, once a month the community health worker will screen the pregnant women for malaria with a rapid diagnostic test and treat with artemether-lumefantrine in case of a positive test result.
Control
NO INTERVENTIONAll pregnant women will be identified in the study area and asked for participation to the study. No intervention will take place.
Interventions
Already described in intervention arm description.
Eligibility Criteria
You may qualify if:
- Residence in the study area and intention to stay in the area for the duration of the pregnancy and for delivery.
- 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.)
- Willing to provide biological samples as and when required during the study period (blood and placental biopsy)
- Informed consent
You may not qualify if:
- A history of sensitivity to sulphonamides.
- Already participating in another research study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Tropical Institutelead
- Medical Research Council Unit, The Gambiacollaborator
- Centre Murazcollaborator
- Imperial College Londoncollaborator
- World Health Organizationcollaborator
- European Unioncollaborator
Study Sites (3)
Centre de Recherches Entomologiques de Cotonou (CREC)
Cotonou, Benin
Clinical Research Unit of Nanoro URCN/CMA, Centre Muraz (CM)
Nanoro, Burkina Faso
Medical Research Council (MRC)
Fajara, The Gambia
Related Publications (4)
Scott S, Mens PF, Tinto H, Nahum A, Ruizendaal E, Pagnoni F, Grietens KP, Kendall L, Bojang K, Schallig H, D'Alessandro U. Community-based scheduled screening and treatment of malaria in pregnancy for improved maternal and infant health in The Gambia, Burkina Faso and Benin: study protocol for a randomized controlled trial. Trials. 2014 Aug 28;15:340. doi: 10.1186/1745-6215-15-340.
PMID: 25169073BACKGROUNDNatama HM, Moncunill G, Vidal M, Rouamba T, Aguilar R, Santano R, Rovira-Vallbona E, Jimenez A, Some MA, Sorgho H, Valea I, Coulibaly-Traore M, Coppel RL, Cavanagh D, Chitnis CE, Beeson JG, Angov E, Dutta S, Gamain B, Izquierdo L, Mens PF, Schallig HDFH, Tinto H, Rosanas-Urgell A, Dobano C. Associations between prenatal malaria exposure, maternal antibodies at birth, and malaria susceptibility during the first year of life in Burkina Faso. Infect Immun. 2023 Oct 17;91(10):e0026823. doi: 10.1128/iai.00268-23. Epub 2023 Sep 27.
PMID: 37754682DERIVEDNatama HM, Moncunill G, Rovira-Vallbona E, Sanz H, Sorgho H, Aguilar R, Coulibaly-Traore M, Some MA, Scott S, Valea I, Mens PF, Schallig HDFH, Kestens L, Tinto H, Dobano C, Rosanas-Urgell A. Modulation of innate immune responses at birth by prenatal malaria exposure and association with malaria risk during the first year of life. BMC Med. 2018 Nov 2;16(1):198. doi: 10.1186/s12916-018-1187-3.
PMID: 30384846DERIVEDCOSMIC Consortium. Community-based Malaria Screening and Treatment for Pregnant Women Receiving Standard Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine: A Multicenter (The Gambia, Burkina Faso, and Benin) Cluster-randomized Controlled Trial. Clin Infect Dis. 2019 Feb 1;68(4):586-596. doi: 10.1093/cid/ciy522.
PMID: 29961848DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Henk Schallig, Dr
Royal Tropical Institute (KIT)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2013
First Posted
September 13, 2013
Study Start
October 1, 2013
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
October 4, 2016
Record last verified: 2015-11