Prevention of Intrauterine Growth Retardation in Burkina Faso: the Malaria Component

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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).

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

Detailed Description:

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment. [ Time Frame: Up to delivery ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	15 Years to 44 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Burkina Faso
Centre Muraz
Bobo-Dioulasso, Burkina Faso, BP 390

Sponsors and Collaborators

Institute of Tropical Medicine, Belgium

Departments of Parasitology and Public Health, ITM, Antwerp, Belgium

Centre Muraz

Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso

Investigators

Principal Investigator:	Marie Claire Henry, MD	Centre Muraz

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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