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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00680732
Other study ID # IUGR Malaria
Secondary ID
Status Completed
Phase Phase 4
First received April 23, 2008
Last updated September 12, 2010
Start date June 2003
Est. completion date October 2006

Study information

Verified date September 2010
Source Institute of Tropical Medicine, Belgium
Contact n/a
Is FDA regulated No
Health authority Burkina Faso: Ministry of Health
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 1370
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 44 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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
Iron and folic acid (IFA)
Iron 60 mg and folic acid 400 mcg
Drug:
Chloroquine (CQ)
Tablets 100 mg of chloroquine base
Sulphadoxyne-pyrimethamine (SP)
Tablets

Locations

Country Name City State
Burkina Faso Centre Muraz Bobo-Dioulasso

Sponsors (4)

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

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment. Up to delivery No
Secondary 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 Yes
Secondary To determine the burden of clinical malaria during pregnancy and its consequences on maternal anaemia, new birth weight and foetal anaemia. Up to delivery Yes
Secondary 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 No
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