Malaria, AntepartumCOSMICNCT01941264
Community-based Screening and Treatment of Malaria in Pregnancy: a Cluster-randomized Trial
A study testing community based screening and treatment in people with Malaria, Antepartum and Maternal Malaria During Pregnancy - Baby Not Yet Delivered, run by Royal Tropical Institute at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria, Antepartum, Maternal Malaria During Pregnancy - Baby Not Yet Delivered, Small for Gestational Age (Disorder)
- What is being tested?
- community based screening and treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,265 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2013to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A history of sensitivity to sulphonamides.
- Already participating in another research study
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Burkina Faso1 site
Clinical Research Unit of Nanoro URCN/CMA, Centre Muraz (CM)
Nanoro
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Malaria, Antepartum, Maternal Malaria During Pregnancy - Baby Not Yet Delivered, Small for Gestational Age (Disorder)
- Being tested
- community based screening and treatment
- Keywords
- malaria, placenta, pregnancy, plasmodium falciparum, screening and treatment, rapid diagnostic test, coartem, artemether-lumefantrine, community health worker
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community based screening and treatmentOther
Also called Rapid diagnostic test, Coartem, Artemether-lumefantrine, malaria village worker
Already described in intervention arm description.
| Study group | Role | What they receive |
|---|---|---|
| community based screening and treatment | Active comparator | 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. Receives: Other: community based screening and treatment |
| Control | No intervention | All pregnant women will be identified in the study area and asked for participation to the study. No intervention will take place. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental malaria
Placental malaria will be diagnosed by microscopy of placental biopsies and polymerase chain reaction (PCR) on placental blood.
Measured: After delivery
Secondary outcomes (1)
Birth weight
Babies of mothers included in the study will be weighed after delivery.
Measured: After delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Malaria, AntepartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 4,265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Tropical Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia, Centre Muraz, Imperial College London, World Health Organization, European Union
- Responsible party
- Sponsor
- Investigators
- Henk Schallig, Dr, Study director, Royal Tropical Institute (KIT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941264
- Sponsor's protocol ID
- 6800110
- Other IDs
- ISRCTN37259296
- Acronym
- COSMIC
- Status last verified
- Nov 2015
- First submitted
- 10 Sep 2013
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 Aug 28;15:340. doi: 10.1186/1745-6215-15-340.
PubMed 25169073Natama HM, Moncunill G, Vidal M, Rouamba T, Aguilar R, Santano R, Rovira-Vallbona E, Jimenez A, Some MA, Sorgho H, Valea I, Coulibaly-Traore M, Coppel RL, Cavanagh D, Chitnis CE, Beeson JG, Angov E, Dutta S, Gamain B, Izquierdo L, Mens PF, Schallig HDFH, Tinto H, Rosanas-Urgell A, Dobano C. Associations between prenatal malaria exposure, maternal antibodies at birth, and malaria susceptibility during the first year of life in Burkina Faso. Infect Immun. 2023 Oct 17;91(10):e0026823. doi: 10.1128/iai.00268-23. Epub 2023 Sep 27.
PubMed 37754682Natama HM, Moncunill G, Rovira-Vallbona E, Sanz H, Sorgho H, Aguilar R, Coulibaly-Traore M, Some MA, Scott S, Valea I, Mens PF, Schallig HDFH, Kestens L, Tinto H, Dobano C, Rosanas-Urgell A. Modulation of innate immune responses at birth by prenatal malaria exposure and association with malaria risk during the first year of life. BMC Med. 2018 Nov 2;16(1):198. doi: 10.1186/s12916-018-1187-3.
PubMed 30384846COSMIC Consortium. Community-based Malaria Screening and Treatment for Pregnant Women Receiving Standard Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine: A Multicenter (The Gambia, Burkina Faso, and Benin) Cluster-randomized Controlled Trial. Clin Infect Dis. 2019 Feb 1;68(4):586-596. doi: 10.1093/cid/ciy522.
PubMed 29961848
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01941264
- Acronym / sponsor ID
- COSMIC / 6800110
- Conditions
- Malaria, Antepartum, Maternal Malaria During Pregnancy - Baby Not Yet Delivered, Small for Gestational Age (Disorder)
- Keywords
- malaria, placenta, pregnancy, plasmodium falciparum, screening and treatment, rapid diagnostic test, coartem, artemether-lumefantrine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,265 participants (actual)
- Lead sponsor
- Royal Tropical InstituteUniversity, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia, Centre Muraz, Imperial College London, World Health Organization, European Union
- Study start
- Oct 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| community based screening and treatment | Active comparator | Other: community based screening and treatmentCHWs 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. |
| Control | No intervention | –All pregnant women will be identified in the study area and asked for participation to the study. No intervention will take place. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- A history of sensitivity to sulphonamides.
- Already participating in another research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| community based screening and treatmentAlso: Rapid diagnostic test, Coartem, Artemether-lumefantrine, malaria village workerAlready described in intervention arm description. | Other | community based screening and treatment |
Primary outcome
Placental malaria
Time frame: After delivery
Placental malaria will be diagnosed by microscopy of placental biopsies and polymerase chain reaction (PCR) on placental blood.
1 secondary outcome
Birth weight
Time frame: After delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Background: PubMed 25169073Scott 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 Aug 28;15:340. doi: 10.1186/1745-6215-15-340.
- Derived from this study: PubMed 37754682Natama HM, Moncunill G, Vidal M, Rouamba T, Aguilar R, Santano R, Rovira-Vallbona E, Jimenez A, Some MA, Sorgho H, Valea I, Coulibaly-Traore M, Coppel RL, Cavanagh D, Chitnis CE, Beeson JG, Angov E, Dutta S, Gamain B, Izquierdo L, Mens PF, Schallig HDFH, Tinto H, Rosanas-Urgell A, Dobano C. Associations between prenatal malaria exposure, maternal antibodies at birth, and malaria susceptibility during the first year of life in Burkina Faso. Infect Immun. 2023 Oct 17;91(10):e0026823. doi: 10.1128/iai.00268-23. Epub 2023 Sep 27.
- Derived from this study: PubMed 30384846Natama HM, Moncunill G, Rovira-Vallbona E, Sanz H, Sorgho H, Aguilar R, Coulibaly-Traore M, Some MA, Scott S, Valea I, Mens PF, Schallig HDFH, Kestens L, Tinto H, Dobano C, Rosanas-Urgell A. Modulation of innate immune responses at birth by prenatal malaria exposure and association with malaria risk during the first year of life. BMC Med. 2018 Nov 2;16(1):198. doi: 10.1186/s12916-018-1187-3.
- Derived from this study: PubMed 29961848COSMIC Consortium. Community-based Malaria Screening and Treatment for Pregnant Women Receiving Standard Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine: A Multicenter (The Gambia, Burkina Faso, and Benin) Cluster-randomized Controlled Trial. Clin Infect Dis. 2019 Feb 1;68(4):586-596. doi: 10.1093/cid/ciy522.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henk Schallig, Dr study director
Royal Tropical Institute (KIT)
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing community based screening and treatment in people with Malaria, Antepartum and Maternal Malaria During Pregnancy - Baby Not Yet Delivered, run by Royal Tropical Institute at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Benin, Burkina Faso, The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placental malaria (time frame: After delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01941264, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.