Prevention of Intrauterine Growth Retardation in Burkina Faso: the Malaria Component
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso: the Malaria Component |
- Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment. [ Time Frame: Up to delivery ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 1370 |
| Study Start Date: | June 2003 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 15 Years to 44 Years |
| Genders 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00680732
| Burkina Faso | |
| Centre Muraz | |
| Bobo-Dioulasso, Burkina Faso, BP 390 | |
| Principal Investigator: | Marie Claire Henry, MD | Centre Muraz |
More Information
No publications provided
| 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 |
| Study First Received: | April 23, 2008 |
| Last Updated: | September 12, 2010 |
| Health Authority: | Burkina Faso: Ministry of Health |
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 Fetal Growth Retardation Malaria Fetal Diseases Growth Disorders Parasitic Diseases Pathologic Processes Protozoan Infections Chloroquine Chloroquine diphosphate Micronutrients Pyrimethamine |
Trace Elements Amebicides Analgesics Analgesics, Non-Narcotic Anthelmintics Anti-Infective Agents Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antimalarials Antinematodal Agents Antiparasitic Agents Antiprotozoal Agents Antirheumatic Agents Central Nervous System Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on March 01, 2015