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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,370 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: Female
• Age: 15 Years – 44 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malaria
• Malaria in Pregnancy

Interventions

Type	Name	Description
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
DIETARY_SUPPLEMENT	Iron and folic acid (IFA)	Iron 60 mg and folic acid 400 mcg
DRUG	Chloroquine (CQ)	Tablets 100 mg of chloroquine base
DRUG	Sulphadoxyne-pyrimethamine (SP)	Tablets

Timeline

• Start date: 2003-06-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2008-05-20
• Last updated: 2010-09-14

Locations

1 site across 1 country: Burkina Faso