Plain English Summary
Background and study aims
Malaria (a tropical disease spread by mosquitoes) is a common disease in Africa and is also a major health problem. Malaria in pregnancy is life threatening to both the mother and the baby. It can cause damage to the mothers blood and can result in babies being born with low birth weight, making them less healthy in their first years of life. These risks are even higher in women having their first child. When a woman is pregnant she should go to the antenatal clinic (ANC) for care. Usually the ANC health staff give her a drug (intermittent preventable treatment [IPTp-SP]) to protect against malaria. Each pregnant woman should receive at least two doses of this drug during their pregnancy. Therefore, they should go the ANC at least twice during their pregnancy. However, many women still do not go often enough to the ANC for health care during their pregnancy. This study aims to find out whether community health workers can work with pregnant women to encourage them to attend the ANC more often.
Who can participate?
Participants will be pregnant women aged 16 years or older who are living in the participating communities.
What does the study involve?
Villages will be randomly allocated to one of two groups. Pregnant women in one group will receive a protective drug against malaria and those in the other group receive standard care. The community health worker will test pregnant women every month for malaria. They will take some finger prick blood and use it for a rapid test. If a woman is found to have malaria, the community health worker will treat this woman in her home instead of her having to go to a health clinic. She will be treated with a different drug than the drug that is given at the ANC visits. We hope this will improve the care and management of malaria during pregnancy and improve the health of women and their newborn babies. To test this, we will take a small piece of the placenta (afterbirth) at delivery to test for malaria and also weigh the baby. We will test this method in multiple communities. We will compare this to pregnant women in communities where this method was not followed.
What are the possible benefits and risks of participating?
There are no direct benefits of participating in the study except that the outcome of our research may have possible health benefits in the group receiving the protective drug. The drugs involved are tested safe in pregnant women from the second trimester onwards.
Where is the study run from?
The study will be run in Benin (Atlantic Region in the southern part of the country, Glo-Djigbé, Zinvié and Zè district communities), Burkina Faso (the Nanoro health district catchment area, which is situated in the centre-west of Burkina Faso) and the Gambia (Basse Health Centre and satellite health facilities; villages situated in the southern and northern bank of the Upper River Region in the eastern part of the country).
When is the study starting and how long is it expected to run for?
The study will begin in September 2013 and is expected to run till March 2015.
Who is funding the study?
This study is funded by the European Commission (Belgium).
Who is the main contact?
Dr. Henk D. F. H. Schallig
h.schallig@kit.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Henk Schallig
ORCID ID
Contact details
Royal Tropical Institute (KIT)
Meibergdreef 39
Amsterdam
1105 AZ
Netherlands
+31 20 5665447
h.schallig@kit.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01941264
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
COSMIC
Study hypothesis
Community-based scheduled screening and treatment of malaria in pregnancy in addition to intermittent preventive treatment in pregnancy will reduce the frequency of placental malaria in pregnant women compared to standard care.
Ethics approval
1. Gambia Government/MRC laboratories Joint Ethics Committee, 25/06/2013, ref: SCC1336
2. Institutional Ethics Committee of Centre Muraz in Burkina Faso, 19/09/2013, ref A20-2013/CE-CM
3. Comite National dEthique pour la Recherché en Santé in Benin, 09/12/2013, No_0126/MS /DC/SGM /DFR /CNERS/SA
Study design
Multi-centre cluster randomized trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Malaria
Intervention
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-based scheduled screening and treatment (IPTp-SP Plus CSST) or continue with the current treatment, i.e. intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) at health facilities when they attend antenatal clinics (ANCs).
Schedule of interventions:
In the intervention arm, women will be encouraged by community health workers to attend the ANC as early as possible during their pregnancy. Health staff will give the first IPTp-SP dose after the first trimester of pregnancy and plan the second dose on the ANC card. Between ANC visits community health workers (CHWs) will perform a monthly rapid diagnostic test (RDT) until the last weeks of gestation and treat any positive woman with artemether-lumefantrine (AL).
In the control arm, women will be recruited at the first ANC visit where staff will explain the study, give the first IPTp-SP dose after the first trimester of pregnancy and plan the second dose on the ANC card.
All women (in both arms) will be encouraged to deliver at health facilities, where a blood sample for haemoglobin measurement and for detection of malaria will be collected just before delivery. A placenta biopsy will be collected at delivery and the newborn examined and weighed. For women not delivering in a health centre, a field assistant (FA) will follow them up at home and will collect the same information and biological samples as at health facilities.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
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.
Overall trial start date
01/09/2013
Overall trial end date
01/03/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
5400
Participant exclusion criteria
1. A history of sensitivity to sulphonamides
2. Already participating in another research study
Recruitment start date
01/09/2013
Recruitment end date
01/03/2015
Locations
Countries of recruitment
Benin, Burkina Faso, Gambia
Trial participating centre
Royal Tropical Institute (KIT)
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Royal Tropical Institute (KIT)
Sponsor details
c/o Dr. Henk Schallig
Biomedical Research
Meibergdreef 39
Amsterdam
1105 AZ
Netherlands
+31 20 5665447
h.schallig@kit.nl
Sponsor type
Other
Website
Funders
Funder type
Government
Funder name
European Commission (Belgium) - ref: FP7-HEALTH-2012-INNOVATION-1305662
Alternative name(s)
EC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25169073
Publication citations
-
Protocol
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, 15, 340, doi: 10.1186/1745-6215-15-340.