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

This study has been completed.
Sponsor:
Collaborators:
Departments of Parasitology and Public Health, ITM, Antwerp, Belgium
Centre Muraz
Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso
Information provided by:
Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier:
NCT00680732
First received: April 23, 2008
Last updated: September 12, 2010
Last verified: September 2010
  Purpose

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).


Condition Intervention Phase
Malaria
Malaria in Pregnancy
Dietary Supplement: Multiple micronutrients supplements (MMS)
Dietary Supplement: Iron and folic acid (IFA)
Drug: Chloroquine (CQ)
Drug: Sulphadoxyne-pyrimethamine (SP)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso: the Malaria Component

Resource links provided by NLM:


Further study details as provided by Institute of Tropical Medicine, Belgium:

Primary Outcome Measures:
  • Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment. [ Time Frame: Up to delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if the occurrence of malaria during pregnancy influences the incidence of clinical malaria in infants during their first year of life. [ Time Frame: Up to one year after delivery ] [ Designated as safety issue: Yes ]
  • To determine the burden of clinical malaria during pregnancy and its consequences on maternal anaemia, new birth weight and foetal anaemia. [ Time Frame: Up to delivery ] [ Designated as safety issue: Yes ]
  • Effect of standard antimalarial treatment on the selection of resistant parasites in pregnant women under weekly chemoprophylaxis or intermittent treatment. [ Time Frame: Up to one year after delivery ] [ Designated as safety issue: No ]

Enrollment: 1370
Study Start Date: June 2003
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: UNIMMAP
Drug: Sulphadoxyne-pyrimethamine (SP)
Tablets
Other Name: Fansidar
Experimental: B1
Iron and folic acid (IFA) and weekly chloroquine (CQ)
Dietary Supplement: Iron and folic acid (IFA)
Iron 60 mg and folic acid 400 mcg
Drug: Chloroquine (CQ)
Tablets 100 mg of chloroquine base
Experimental: B2
Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP)
Dietary Supplement: Iron and folic acid (IFA)
Iron 60 mg and folic acid 400 mcg
Drug: Sulphadoxyne-pyrimethamine (SP)
Tablets
Other Name: Fansidar

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.

  Eligibility

Ages Eligible for Study:   15 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680732

Locations
Burkina Faso
Centre Muraz
Bobo-Dioulasso, Burkina Faso, BP 390
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
Departments of Parasitology and Public Health, ITM, Antwerp, Belgium
Centre Muraz
Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso
Investigators
Principal Investigator: Marie Claire Henry, MD Centre Muraz
  More Information

No publications provided

Responsible Party: Prof. Umberto D'Alessandro, Head of the Parasitology Department, ITM
ClinicalTrials.gov Identifier: NCT00680732     History of Changes
Other Study ID Numbers: IUGR Malaria
Study First Received: April 23, 2008
Last Updated: September 12, 2010
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by Institute of Tropical Medicine, Belgium:
Malaria
Pregnancy
Prevention
Chloroquine
Sulphadoxine pyrimethamine
Maternal anaemia
Birth weight
Foetal anaemia

Additional relevant MeSH terms:
Pregnancy Complications
Folic Acid
Vitamin B Complex
Folic Acid Antagonists
Fetal Growth Retardation
Malaria
Fetal Diseases
Growth Disorders
Parasitic Diseases
Pathologic Processes
Protozoan Infections
Chloroquine
Chloroquine diphosphate
Micronutrients
Pyrimethamine
Trace Elements
Amebicides
Analgesics
Analgesics, Non-Narcotic
Anthelmintics
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimalarials
Antinematodal Agents
Antiparasitic Agents
Antiprotozoal Agents
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014