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| Name | Class |
|---|---|
| Departments of Parasitology and Public Health, ITM, Antwerp, Belgium | UNKNOWN |
| Centre Muraz | OTHER |
| Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso | UNKNOWN |
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Our objective was to investigate the importance of malaria infection/disease during pregnancy and more particularly during the first trimester; we also looked at the maternal-foetal interactions and their influence on the subsequent child's response to malaria infections during the first year of life. This study was carried out !in the same population recruited for the IUGR study (NCT00642408).
A research project aiming at investigating the impact of multivitamin-mineral supplementation (MMS) during pregnancy on intra-uterin growth retardation was carried out in the Hounde district, an area not far from the Centre Muraz located in Bobo Dioulasso, and where malaria is endemic. Malaria during pregnancy increases the risk of low birth weight, infant mortality and morbidity during the first year of life by inducing growth retardation, prematurity and infant anaemia.
The administration of an antimalarial drug during pregnancy has a beneficial effect on the mother and child's health by preventing malaria infection and its consequences. However, most studies have been carried out during the second or third trimester of pregnancy: the effect of malaria infection during the first trimester on the mother's and child's health is unknown. It has been reported that even one single infection may have a significant impact on the outcome of pregnancy: if it is true, then early chemoprophylaxis may have an additional advantage.
An alternative approach is the administration of intermittent presumptive treatment, which may achieve equal efficacy to continuos chemoprophylaxis; however, no studies compared effective weekly malaria chemoprophylaxis with effective intermittent presumptive treatment. Moreover, the incidence of malaria clinical episodes during SP intermittent preventive treatment has never been investigated.
Therefore, this open label, factorial study was carried out in the same women recruited for the IUGR nutritional study (NCT00642408). Women receiving multiple micronutrients supplements (MMS) or dietary supplements (IFA) were further randomised in 2 groups: CQ weekly chemoprophylaxis or SP intermittent preventive treatment. The administration of treatment was directly observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental | Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ) |
|
| A2 | Experimental | Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP) |
|
| B1 | Experimental | Iron and folic acid (IFA) and weekly chloroquine (CQ) |
|
| B2 | Experimental | Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple micronutrients supplements (MMS) | Dietary Supplement | Vitamin A 800 mcg; vitamin E 10 mg; vitamin D 5 mcg; vitamin B1 1.4 mg; vitamin B2 1.4 mg;niacin 18 mg; vitamin B6 1.9 mg; vitamin B12 2.6 mcg; folic acid 400 mcg; vitamin C 70 mg; iron 30 mg; zinc 15 mg; copper 2 mg; selenium 65 mcg; iodine 150 mcg |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment. | Up to delivery |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if the occurrence of malaria during pregnancy influences the incidence of clinical malaria in infants during their first year of life. | Up to one year after delivery | |
| To determine the burden of clinical malaria during pregnancy and its consequences on maternal anaemia, new birth weight and foetal anaemia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Claire Henry, MD | Centre Muraz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Muraz | Bobo-Dioulasso | BP 390 | Burkina Faso |
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|
|
| Iron and folic acid (IFA) | Dietary Supplement | Iron 60 mg and folic acid 400 mcg |
|
| Chloroquine (CQ) | Drug | Tablets 100 mg of chloroquine base |
|
| Sulphadoxyne-pyrimethamine (SP) | Drug | Tablets |
|
|
| Up to delivery |
| Effect of standard antimalarial treatment on the selection of resistant parasites in pregnant women under weekly chemoprophylaxis or intermittent treatment. | Up to one year after delivery |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D001724 | Birth Weight |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007501 | Iron |
| D005492 | Folic Acid |
| D002738 | Chloroquine |
| C001205 | fanasil, pyrimethamine drug combination |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
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