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

October 3, 2016 updated by: Royal Tropical Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

4265

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Benin
      • Cotonou, Benin
        • Centre de Recherches Entomologiques de Cotonou (CREC)
  • Burkina Faso
      • Nanoro, Burkina Faso
        • Clinical Research Unit of Nanoro URCN/CMA, Centre Muraz (CM)
  • Gambia
      • Fajara, Gambia
        • Medical Research Council (MRC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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:
  • Coartem
  • Rapid diagnostic test
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Placental malaria
Time Frame: After delivery
Placental malaria will be diagnosed by microscopy of placental biopsies and polymerase chain reaction (PCR) on placental blood.
After delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth weight
Time Frame: After delivery
Babies of mothers included in the study will be weighed after delivery.
After delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Throughout inclusion (+/- 6 months)
Resistance to sulphadoxine-pyrimethamine (SP)
Time Frame: At delivery
Samples infected with P.falciparum will be checked for resistance profile for sulphadoxine-pyrimethamine
At delivery
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.
Throughout inclusion (+/- 6 months)
hemoglobin
Time Frame: At delivery
Peripheral blood sample will be tested for hemoglobin
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Tropical Institute

Collaborators

Imperial College London
World Health Organization
Medical Research Council Unit, The Gambia
European Union
Centre Muraz

Investigators

  • Study Director: Henk Schallig, Dr, Royal Tropical Institute (KIT)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6800110
  • ISRCTN37259296 (Registry Identifier: ISRCTN register)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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