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

Primary Purpose

Malaria, Malaria in Pregnancy

Status
Completed
Phase
Phase 4
Locations
Burkina Faso
Study Type
Interventional
Intervention
Multiple micronutrients supplements (MMS)
Iron and folic acid (IFA)
Chloroquine (CQ)
Sulphadoxyne-pyrimethamine (SP)
Sponsored by
Institute of Tropical Medicine, Belgium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring Malaria, Pregnancy, Prevention, Chloroquine, Sulphadoxine pyrimethamine, Maternal anaemia, Birth weight, Foetal anaemia

Eligibility Criteria

15 Years - 44 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Muraz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

A1

A2

B1

B2

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

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.
To determine the burden of clinical malaria during pregnancy and its consequences on maternal anaemia, new birth weight and foetal anaemia.
Effect of standard antimalarial treatment on the selection of resistant parasites in pregnant women under weekly chemoprophylaxis or intermittent treatment.

Full Information

First Posted
April 23, 2008
Last Updated
September 12, 2010
Sponsor
Institute of Tropical Medicine, Belgium
Collaborators
Departments of Parasitology and Public Health, ITM, Antwerp, Belgium, Centre Muraz, Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso
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1. Study Identification

Unique Protocol Identification Number
NCT00680732
Brief Title
Prevention of Intrauterine Growth Retardation in Burkina Faso: the Malaria Component
Official Title
Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso: the Malaria Component
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institute of Tropical Medicine, Belgium
Collaborators
Departments of Parasitology and Public Health, ITM, Antwerp, Belgium, Centre Muraz, Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Malaria in Pregnancy
Keywords
Malaria, Pregnancy, Prevention, Chloroquine, Sulphadoxine pyrimethamine, Maternal anaemia, Birth weight, Foetal anaemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1370 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Experimental
Arm Description
Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ)
Arm Title
A2
Arm Type
Experimental
Arm Description
Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP)
Arm Title
B1
Arm Type
Experimental
Arm Description
Iron and folic acid (IFA) and weekly chloroquine (CQ)
Arm Title
B2
Arm Type
Experimental
Arm Description
Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP)
Intervention Type
Dietary Supplement
Intervention Name(s)
Multiple micronutrients supplements (MMS)
Other Intervention Name(s)
UNIMMAP
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Iron and folic acid (IFA)
Intervention Description
Iron 60 mg and folic acid 400 mcg
Intervention Type
Drug
Intervention Name(s)
Chloroquine (CQ)
Intervention Description
Tablets 100 mg of chloroquine base
Intervention Type
Drug
Intervention Name(s)
Sulphadoxyne-pyrimethamine (SP)
Other Intervention Name(s)
Fansidar
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment.
Time Frame
Up to delivery
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Claire Henry, MD
Organizational Affiliation
Centre Muraz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Muraz
City
Bobo-Dioulasso
ZIP/Postal Code
BP 390
Country
Burkina Faso

12. IPD Sharing Statement

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

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