Prevention of Intrauterine Growth Retardation in Burkina Faso: the Malaria Component
Condition: Malaria; Malaria in Pregnancy
MeSH terms: Malaria; Fetal Growth Retardation
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Multiple micronutrients supplements (MMS); Iron and folic acid (IFA); Chloroquine (CQ); Sulphadoxyne-pyrimethamine (SP)
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug; Drug
Intervention description(s): 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; Iron 60 mg and folic acid 400 mcg; Tablets 100 mg of chloroquine base; Tablets
Other intervention name(s): UNIMMAP; Fansidar
Intervention MeSH terms: Folic Acid; Micronutrients; Trace Elements; Chloroquine; Pyrimethamine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria; Pregnancy; Prevention; Chloroquine; Sulphadoxine pyrimethamine; Maternal anaemia; Birth weight; Foetal anaemia