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 (COSMIC)
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.
Maternal Malaria During Pregnancy - Baby Not Yet Delivered
Small for Gestational Age (Disorder)
Other: community based screening and treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official 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|
- Placental malaria [ Time Frame: After delivery ] [ Designated as safety issue: No ]Placental malaria will be diagnosed by microscopy of placental biopsies and polymerase chain reaction (PCR) on placental blood.
- Birth weight [ Time Frame: After delivery ] [ Designated as safety issue: No ]Babies of mothers included in the study will be weighed after delivery.
- antenatal care clinic attendance [ Time Frame: Throughout inclusion (+/- 6 months) ] [ Designated as safety issue: No ]A field worker will identify all eligible pregnant women and will follow-up on ANC attendance through lists at the antenatal care clinic
- Resistance to sulphadoxine-pyrimethamine (SP) [ Time Frame: At delivery ] [ Designated as safety issue: No ]Samples infected with P.falciparum will be checked for resistance profile for sulphadoxine-pyrimethamine
- Peripheral malaria infection [ Time Frame: Throughout inclusion (+/- 6 months) ] [ Designated as safety issue: No ]Each collected filter paper en microscopy slide (both in antenatal care clinics and from community health worker visits) will be checked for the presence of malaria parasites.
- hemoglobin [ Time Frame: At delivery ] [ Designated as safety issue: No ]Peripheral blood sample will be tested for hemoglobin
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Active Comparator: community based screening and treatment
CHWs 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.
Other: community based screening and treatment
No Intervention: Control
All pregnant women will be identified in the study area and asked for participation to the study. No intervention will take place.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01941264
|Contact: Umberto D'Alessandro, firstname.lastname@example.org|
|Contact: Susana Scott, Dremail@example.com|
|Centre de Recherches Entomologiques de Cotonou (CREC)||Not yet recruiting|
|Contact: Alain Nahum, Dr firstname.lastname@example.org|
|Contact: Daniel Ahounou email@example.com|
|Principal Investigator: Alain Nahum, Dr|
|Clinical Research Unit of Nanoro URCN/CMA, Centre Muraz (CM)||Not yet recruiting|
|Nanoro, Burkina Faso|
|Contact: Halidou Tinto, Dr firstname.lastname@example.org|
|Contact: Maminata Traore, Dr email@example.com|
|Principal Investigator: Halidou Tinto, Dr|
|Medical Research Council (MRC)||Not yet recruiting|
|Contact: Umberto d'Alessandro, professor firstname.lastname@example.org|
|Contact: Susana Scott, Dr email@example.com|
|Principal Investigator: Umberto d'Alessandro, professor|
|Study Director:||Henk Schallig, Dr||Royal Tropical Institute (KIT)|