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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Royal Tropical Institute
Sponsor:
Collaborators:
Medical Research Council Unit, The Gambia
Centre Muraz
Imperial College London
World Health Organization
European Union
Information provided by (Responsible Party):
Royal Tropical Institute
ClinicalTrials.gov Identifier:
NCT01941264
First received: September 10, 2013
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Royal Tropical Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Birth weight [ Time Frame: After delivery ] [ Designated as safety issue: No ]
    Babies of mothers included in the study will be weighed after delivery.


Other Outcome Measures:
  • 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


Estimated Enrollment: 5400
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941264

Contacts
Contact: Umberto D'Alessandro, professor udalessandro@mrc.gm
Contact: Susana Scott, Dr sscott@mrc.gm

Locations
Benin
Centre de Recherches Entomologiques de Cotonou (CREC) Recruiting
Cotonou, Benin
Contact: Alain Nahum, Dr       nahum_alain@yahoo.fr   
Contact: Daniel Ahounou       danahoun@yahoo.fr   
Principal Investigator: Alain Nahum, Dr         
Burkina Faso
Clinical Research Unit of Nanoro URCN/CMA, Centre Muraz (CM) Recruiting
Nanoro, Burkina Faso
Contact: Halidou Tinto, Dr       tintoh@fasonet.bf   
Contact: Maminata Traore, Dr       traore_maminata@yahoo.fr   
Principal Investigator: Halidou Tinto, Dr         
Gambia
Medical Research Council (MRC) Recruiting
Fajara, Gambia
Contact: Umberto d'Alessandro, professor       udalessandro@mrc.gm   
Contact: Susana Scott, Dr       sscott@mrc.gm   
Principal Investigator: Umberto d'Alessandro, professor         
Sponsors and Collaborators
Royal Tropical Institute
Medical Research Council Unit, The Gambia
Centre Muraz
Imperial College London
World Health Organization
European Union
Investigators
Study Director: Henk Schallig, Dr Royal Tropical Institute (KIT)
  More Information

Additional Information:
Publications:
Responsible Party: Royal Tropical Institute
ClinicalTrials.gov Identifier: NCT01941264     History of Changes
Other Study ID Numbers: 6800110, ISRCTN37259296
Study First Received: September 10, 2013
Last Updated: November 4, 2014
Health Authority: Gambia: MRC Ethics Committee

Keywords provided by Royal Tropical Institute:
malaria
placenta
pregnancy
plasmodium falciparum
screening and treatment
rapid diagnostic test
coartem
artemether-lumefantrine
community health worker

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections
Artemether
Artemether-lumefantrine combination
Artemisinins
Lumefantrine
Anthelmintics
Anti-Infective Agents
Antifungal Agents
Antimalarials
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Coccidiostats
Pharmacologic Actions
Schistosomicides
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014