- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680732
Prevention of Intrauterine Growth Retardation in Burkina Faso: the Malaria Component
Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso: the Malaria Component
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Bobo-Dioulasso, Burkina Faso, BP 390
- Centre Muraz
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A1
Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ)
|
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 Names:
Tablets 100 mg of chloroquine base
|
Experimental: A2
Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP)
|
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 Names:
Tablets
Other Names:
|
Experimental: B1
Iron and folic acid (IFA) and weekly chloroquine (CQ)
|
Tablets 100 mg of chloroquine base
Iron 60 mg and folic acid 400 mcg
|
Experimental: B2
Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP)
|
Tablets
Other Names:
Iron 60 mg and folic acid 400 mcg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment.
Time Frame: Up to delivery
|
Up to delivery
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Secondary Outcome Measures
Outcome Measure |
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.
Time Frame: Up to one year after delivery
|
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
|
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
|
Up to one year after delivery
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marie Claire Henry, MD, Centre Muraz
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Fetal Diseases
- Pregnancy Complications
- Growth Disorders
- Malaria
- Fetal Growth Retardation
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Vitamins
- Antiprotozoal Agents
- Antiparasitic Agents
- Vitamin B Complex
- Hematinics
- Antimalarials
- Amebicides
- Folic Acid Antagonists
- Chloroquine
- Micronutrients
- Trace Elements
- Folic Acid
- Pyrimethamine
Other Study ID Numbers
- IUGR Malaria
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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