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

NCT00680732 | Completed Phase 4

• 1 other identifier: IUGR Malaria
• Study Type: interventional
• Target: 1,370
• Locations: 1 country
• Sites: 1

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).

Conditions

Malaria; Malaria in Pregnancy

Keywords

Malaria; Pregnancy; Prevention; Chloroquine; Sulphadoxine pyrimethamine; Maternal anaemia; Birth weight; Foetal anaemia

Outcome Measures

Primary Outcomes (1)

• Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment.

  Up to delivery

Secondary Outcomes (3)

• 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

Study Arms (4)

A1

EXPERIMENTAL

Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ)

Dietary Supplement: Multiple micronutrients supplements (MMS); Drug: Chloroquine (CQ)

A2

EXPERIMENTAL

Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP)

Dietary Supplement: Multiple micronutrients supplements (MMS); Drug: Sulphadoxyne-pyrimethamine (SP)

B1

EXPERIMENTAL

Iron and folic acid (IFA) and weekly chloroquine (CQ)

Dietary Supplement: Iron and folic acid (IFA); Drug: Chloroquine (CQ)

B2

EXPERIMENTAL

Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP)

Dietary Supplement: Iron and folic acid (IFA); Drug: Sulphadoxyne-pyrimethamine (SP)

Interventions

Multiple micronutrients supplements (MMS) DIETARY_SUPPLEMENT

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

Also known as: UNIMMAP

A1; A2

Iron and folic acid (IFA) DIETARY_SUPPLEMENT

Iron 60 mg and folic acid 400 mcg

B1; B2

Chloroquine (CQ) DRUG

Tablets 100 mg of chloroquine base

A1; B1

Sulphadoxyne-pyrimethamine (SP) DRUG

Tablets

Also known as: Fansidar

A2; B2

Eligibility Criteria

• Age: 15 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 44 years
• females
• living in the study area

You may not qualify if:

• planning to move outside the district within two years
• regularly using a contraceptive methods
• already pregnant at the start of the trial

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Departments of Parasitology and Public Health, ITM, Antwerp, Belgium: collaborator
• Centre Muraz: collaborator
• Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso: collaborator

Study Sites (1)

Centre Muraz

Bobo-Dioulasso, BP 390, Burkina Faso

Location

MeSH Terms

Conditions

Malaria; Birth Weight

Interventions

Iron; Folic Acid; Chloroquine; fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminoquinolines; Quinolines

Study Officials

• Marie Claire Henry, MD

  Centre Muraz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: May 20, 2008
• Study Start: June 1, 2003
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

BU (1)