Malaria, Antepartum Clinical Trial
— COSMICOfficial 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
| Verified date | November 2015 |
| Source | Royal Tropical Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Gambia: MRC Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 4265 |
| Est. completion date | May 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 16 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Benin | Centre de Recherches Entomologiques de Cotonou (CREC) | Cotonou | |
| Burkina Faso | Clinical Research Unit of Nanoro URCN/CMA, Centre Muraz (CM) | Nanoro | |
| Gambia | Medical Research Council (MRC) | Fajara |
| Lead Sponsor | Collaborator |
|---|---|
| Royal Tropical Institute | Centre Muraz, European Union, Imperial College London, Medical Research Council Unit, The Gambia, World Health Organization |
Benin, Burkina Faso, Gambia,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | antenatal care clinic attendance | 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) | No |
| Other | Resistance to sulphadoxine-pyrimethamine (SP) | Samples infected with P.falciparum will be checked for resistance profile for sulphadoxine-pyrimethamine | At delivery | No |
| Other | Peripheral malaria infection | 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) | No |
| Other | hemoglobin | Peripheral blood sample will be tested for hemoglobin | At delivery | No |
| Primary | Placental malaria | Placental malaria will be diagnosed by microscopy of placental biopsies and polymerase chain reaction (PCR) on placental blood. | After delivery | No |
| Secondary | Birth weight | Babies of mothers included in the study will be weighed after delivery. | After delivery | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06162078 -
Malaria Burden in Pregnant Women and the Incidence of Pregnancy in a Cohort of Nulligravida
|