Prevention of Intrauterine Growth Retardation in Burkina Faso: the Malaria Component
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ClinicalTrials.gov Identifier: NCT00680732 |
Recruitment Status
:
Completed
First Posted
: May 20, 2008
Last Update Posted
: September 14, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malaria Malaria in Pregnancy | Dietary Supplement: Multiple micronutrients supplements (MMS) Dietary Supplement: Iron and folic acid (IFA) Drug: Chloroquine (CQ) Drug: Sulphadoxyne-pyrimethamine (SP) | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1370 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso: the Malaria Component |
Study Start Date : | June 2003 |
Actual Primary Completion Date : | October 2006 |
Actual Study Completion Date : | October 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: A1
Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ)
|
Dietary Supplement: Multiple micronutrients supplements (MMS)
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
Other Name: UNIMMAP
Drug: Chloroquine (CQ)
Tablets 100 mg of chloroquine base
|
Experimental: A2
Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP)
|
Dietary Supplement: Multiple micronutrients supplements (MMS)
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
Other Name: UNIMMAP
Drug: Sulphadoxyne-pyrimethamine (SP)
Tablets
Other Name: Fansidar
|
Experimental: B1
Iron and folic acid (IFA) and weekly chloroquine (CQ)
|
Dietary Supplement: Iron and folic acid (IFA)
Iron 60 mg and folic acid 400 mcg
Drug: Chloroquine (CQ)
Tablets 100 mg of chloroquine base
|
Experimental: B2
Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP)
|
Dietary Supplement: Iron and folic acid (IFA)
Iron 60 mg and folic acid 400 mcg
Drug: Sulphadoxyne-pyrimethamine (SP)
Tablets
Other Name: Fansidar
|
- Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment. [ Time Frame: Up to delivery ]
- To determine if the occurrence of malaria during pregnancy influences the incidence of clinical malaria in infants during their first year of life. [ Time Frame: 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. [ Time Frame: Up to delivery ]
- Effect of standard antimalarial treatment on the selection of resistant parasites in pregnant women under weekly chemoprophylaxis or intermittent treatment. [ Time Frame: Up to one year after delivery ]

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Ages Eligible for Study: | 15 Years to 44 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 15 to 44 years
- females
- living in the study area
Exclusion Criteria:
- planning to move outside the district within two years
- regularly using a contraceptive methods
- already pregnant at the start of the trial

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680732
Burkina Faso | |
Centre Muraz | |
Bobo-Dioulasso, Burkina Faso, BP 390 |
Principal Investigator: | Marie Claire Henry, MD | Centre Muraz |
Responsible Party: | Prof. Umberto D'Alessandro, Head of the Parasitology Department, ITM |
ClinicalTrials.gov Identifier: | NCT00680732 History of Changes |
Other Study ID Numbers: |
IUGR Malaria |
First Posted: | May 20, 2008 Key Record Dates |
Last Update Posted: | September 14, 2010 |
Last Verified: | September 2010 |
Keywords provided by Institute of Tropical Medicine, Belgium:
Malaria Pregnancy Prevention Chloroquine |
Sulphadoxine pyrimethamine Maternal anaemia Birth weight Foetal anaemia |
Additional relevant MeSH terms:
Pregnancy Complications Folic Acid Vitamin B Complex Folic Acid Antagonists Malaria Fetal Growth Retardation Protozoan Infections Parasitic Diseases Fetal Diseases Growth Disorders Pathologic Processes Iron Trace Elements Micronutrients Chloroquine |
Chloroquine diphosphate Pyrimethamine Growth Substances Physiological Effects of Drugs Hematinics Vitamins Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antimalarials Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |