Prevention of Intrauterine Growth Retardation in Burkina Faso: the Malaria Component
Information source: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria; Malaria in Pregnancy
Intervention: Multiple micronutrients supplements (MMS) (Dietary Supplement); Iron and folic acid (IFA) (Dietary Supplement); Chloroquine (CQ) (Drug); Sulphadoxyne-pyrimethamine (SP) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Institute of Tropical Medicine, Belgium Official(s) and/or principal investigator(s):
Marie Claire Henry, MD, Principal Investigator, Affiliation: Centre Muraz
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).
Clinical Details
Official title: Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso: the Malaria Component
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment.
Secondary outcome: To determine if the occurrence of malaria during pregnancy influences the incidence of clinical malaria in infants during their first year of life.To determine the burden of clinical malaria during pregnancy and its consequences on maternal anaemia, new birth weight and foetal anaemia. Effect of standard antimalarial treatment on the selection of resistant parasites in pregnant women under weekly chemoprophylaxis or intermittent treatment.
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
Minimum age: 15 Years.
Maximum age: 44 Years.
Gender(s): Female.
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
Locations and Contacts
Centre Muraz, Bobo-Dioulasso BP 390, Burkina Faso
Additional Information
Starting date: June 2003
Last updated: September 12, 2010
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