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

Phase 4

Completed

• Conditions: Malaria; Malaria in Pregnancy
• Interventions: Dietary Supplement: Multiple micronutrients supplements (MMS); Dietary Supplement: Iron and folic acid (IFA); Drug: Chloroquine (CQ); Drug: Sulphadoxyne-pyrimethamine (SP)

• Registration Number: NCT00680732
• Lead Sponsor: Institute of Tropical Medicine, Belgium

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.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-20
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-12
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1370

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A1	Multiple micronutrients supplements (MMS)	Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ)
A1	Chloroquine (CQ)	Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ)
A2	Multiple micronutrients supplements (MMS)	Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP)
A2	Sulphadoxyne-pyrimethamine (SP)	Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP)
B1	Iron and folic acid (IFA)	Iron and folic acid (IFA) and weekly chloroquine (CQ)
B1	Chloroquine (CQ)	Iron and folic acid (IFA) and weekly chloroquine (CQ)
B2	Iron and folic acid (IFA)	Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP)
B2	Sulphadoxyne-pyrimethamine (SP)	Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Muraz; 🇧🇫 Bobo-Dioulasso, Burkina Faso