Community-based Screening and Treatment of Malaria in Pregnancy: a Cluster-randomized Trial (COSMIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01941264
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : October 4, 2016
Medical Research Council Unit, The Gambia
Centre Muraz
Imperial College London
World Health Organization
European Union
Information provided by (Responsible Party):
Royal Tropical Institute

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.

Condition or disease Intervention/treatment Phase
Malaria, Antepartum Maternal Malaria During Pregnancy - Baby Not Yet Delivered Small for Gestational Age (Disorder) Other: community based screening and treatment Not Applicable

Detailed Description:

Community health workers (CHWs) that will be working in intervention villages will be trained on community-based case management of malaria by monthly testing of pregnant women using a rapid diagnostic test (RDT). They will also be taught the benefit of pregnant women visiting the antenatal clinics (ANC) and that women should receive intermittent preventive treatment with sulphadoxine-pyrimethamine (SP) at the ANC according to WHO guidelines.

The CHWs will try to identify all pregnant women in their villages and encourage them to visit the ANC as early as possible in their pregnancy. The CHW will check after one week if the ANC was visited. For women who do not attend the ANC, the CHW will further encourage and discuss reasons for non-attendance. Subsequently the CHW will visit the woman's house every month to test for malaria with a RDT.The CHW will give a full course of AL to any woman with a positive RDT. The CHW will also collect a blood slide and a blood spot on filter paper for later analysis in the laboratory. The CHWs will return to women who were treated for malaria to check uptake and compliance by using a short questionnaire and checking the empty packaging of the treatment at the end of the course.

In control communities, CHW will not be trained to do RDTs and give AL to pregnant women. The only data collection will occur during ANC visits.

All women are asked to deliver in collaborating health centres. Peripheral blood will be tested for hemoglobin, malaria infection and resistance against SP. A placenta biopsy will be collected and all babies will be weighed and examined.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : October 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
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
Already described in intervention arm description.
Other Names:
  • Rapid diagnostic test
  • Coartem
  • Artemether-lumefantrine
  • malaria village worker
  • village health worker
  • community case management

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.

Primary Outcome Measures :
  1. Placental malaria [ Time Frame: After delivery ]
    Placental malaria will be diagnosed by microscopy of placental biopsies and polymerase chain reaction (PCR) on placental blood.

Secondary Outcome Measures :
  1. Birth weight [ Time Frame: After delivery ]
    Babies of mothers included in the study will be weighed after delivery.

Other Outcome Measures:
  1. antenatal care clinic attendance [ Time Frame: Throughout inclusion (+/- 6 months) ]
    A field worker will identify all eligible pregnant women and will follow-up on ANC attendance through lists at the antenatal care clinic

  2. Resistance to sulphadoxine-pyrimethamine (SP) [ Time Frame: At delivery ]
    Samples infected with P.falciparum will be checked for resistance profile for sulphadoxine-pyrimethamine

  3. Peripheral malaria infection [ Time Frame: Throughout inclusion (+/- 6 months) ]
    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.

  4. hemoglobin [ Time Frame: At delivery ]
    Peripheral blood sample will be tested for hemoglobin

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • A history of sensitivity to sulphonamides.
  • Already participating in another research study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01941264

Centre de Recherches Entomologiques de Cotonou (CREC)
Cotonou, Benin
Burkina Faso
Clinical Research Unit of Nanoro URCN/CMA, Centre Muraz (CM)
Nanoro, Burkina Faso
Medical Research Council (MRC)
Fajara, Gambia
Sponsors and Collaborators
Royal Tropical Institute
Medical Research Council Unit, The Gambia
Centre Muraz
Imperial College London
World Health Organization
European Union
Study Director: Henk Schallig, Dr Royal Tropical Institute (KIT)

Responsible Party: Royal Tropical Institute Identifier: NCT01941264     History of Changes
Other Study ID Numbers: 6800110
ISRCTN37259296 ( Registry Identifier: ISRCTN register )
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: November 2015

Keywords provided by Royal Tropical Institute:
plasmodium falciparum
screening and treatment
rapid diagnostic test
community health worker

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Antiplatyhelmintic Agents