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

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

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).

Study Overview

• Status: Completed
• Conditions: Malaria; Malaria in Pregnancy
• Intervention / Treatment: Dietary supplement: Multiple micronutrients supplements (MMS); Drug: Chloroquine (CQ); Drug: Sulphadoxyne-pyrimethamine (SP); Dietary supplement: Iron and folic acid (IFA)

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 Type: Interventional
• Enrollment (Actual): 1370
• Phase: Phase 4

Contacts and Locations

Study Locations

• Burkina Faso
  • Bobo-Dioulasso, Burkina Faso, BP 390
    • Centre Muraz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A1; Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ)	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; Other Names: UNIMMAP; Drug: Chloroquine (CQ); Tablets 100 mg of chloroquine base
Experimental: A2; Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP)	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; Other Names: UNIMMAP; Drug: Sulphadoxyne-pyrimethamine (SP); Tablets; Other Names: Fansidar
Experimental: B1; Iron and folic acid (IFA) and weekly chloroquine (CQ)	Drug: Chloroquine (CQ); Tablets 100 mg of chloroquine base; Dietary supplement: Iron and folic acid (IFA); Iron 60 mg and folic acid 400 mcg
Experimental: B2; Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP)	Drug: Sulphadoxyne-pyrimethamine (SP); Tablets; Other Names: Fansidar; Dietary supplement: Iron and folic acid (IFA); Iron 60 mg and folic acid 400 mcg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Collaborators: Centre Muraz; Departments of Parasitology and Public Health, ITM, Antwerp, Belgium; Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso
• Investigators: Principal Investigator: Marie Claire Henry, MD, Centre Muraz

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: April 23, 2008
• First Submitted That Met QC Criteria: May 15, 2008
• First Posted (Estimate): May 20, 2008

Study Record Updates

• Last Update Posted (Estimate): September 14, 2010
• Last Update Submitted That Met QC Criteria: September 12, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Pregnancy; Birth weight; Malaria; Prevention; Chloroquine; Sulphadoxine pyrimethamine; Maternal anaemia; Foetal anaemia
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Fetal Diseases; Pregnancy Complications; Growth Disorders; Malaria; Fetal Growth Retardation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Vitamins; Antiprotozoal Agents; Antiparasitic Agents; Vitamin B Complex; Hematinics; Antimalarials; Amebicides; Folic Acid Antagonists; Chloroquine; Micronutrients; Trace Elements; Folic Acid; Pyrimethamine
• Other Study ID Numbers: IUGR Malaria