Malaria, Antepartum Clinical 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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06162078 -
Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida
|