Clinical trial NCT01941264: Community-based Screening and Treatment of Malaria in Pregnancy: a Cluster-randomized Trial
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
community health worker
Lead sponsor: Royal Tropical Institute
Sponsor class: OTHER
Collaborators: name: Medical Research Council Unit, The Gambia
name: Centre Muraz
name: Imperial College London
name: World Health Organization
name: European Union
First posted: 2013-09-13
Enrollment: 4265
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Placental malaria
timeFrame: After delivery
Secondary outcomes:
measure: Birth weight
timeFrame: After delivery
Other outcomes:
measure: antenatal care clinic attendance
timeFrame: Throughout inclusion (+/- 6 months)
measure: Resistance to sulphadoxine-pyrimethamine (SP)
timeFrame: At delivery
measure: Peripheral malaria infection
timeFrame: Throughout inclusion (+/- 6 months)
measure: hemoglobin
timeFrame: At delivery
Locations:
city: Cotonou
country: Benin
facility: Centre de Recherches Entomologiques de Cotonou (CREC)
city: Nanoro
country: Burkina Faso
facility: Clinical Research Unit of Nanoro URCN/CMA, Centre Muraz (CM)
city: Fajara
country: Gambia
facility: Medical Research Council (MRC)
Study officials:
affiliation: Royal Tropical Institute (KIT)
name: Henk Schallig, Dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Natama 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.
citation: COSMIC 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.