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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680732
• Other study ID #: IUGR Malaria
• 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

• Fetal Growth Retardation
• Malaria
• Malaria in Pregnancy

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