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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00680732
Enrollment
1370
Registered
2008-05-20
Start date
2003-06-30
Completion date
2006-10-31
Last updated
2010-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria, Malaria in Pregnancy

Keywords

Malaria, Pregnancy, Prevention, Chloroquine, Sulphadoxine pyrimethamine, Maternal anaemia, Birth weight, Foetal anaemia

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).

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.

Interventions

DIETARY_SUPPLEMENTMultiple 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

DIETARY_SUPPLEMENTIron and folic acid (IFA)

Iron 60 mg and folic acid 400 mcg

Tablets 100 mg of chloroquine base

DRUGSulphadoxyne-pyrimethamine (SP)

Tablets

Sponsors

Departments of Parasitology and Public Health, ITM, Antwerp, Belgium
CollaboratorUNKNOWN
Centre Muraz
CollaboratorOTHER
Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso
CollaboratorUNKNOWN
Institute of Tropical Medicine, Belgium
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 44 Years
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

Design outcomes

Primary

MeasureTime frame
Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment.Up to delivery

Secondary

MeasureTime 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.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

Countries

Burkina Faso

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026