Clinical trial NCT00680732: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Malaria in Pregnancy
Keywords: Malaria
Pregnancy
Prevention
Chloroquine
Sulphadoxine pyrimethamine
Maternal anaemia
Birth weight
Foetal anaemia
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Departments of Parasitology and Public Health, ITM, Antwerp, Belgium
name: Centre Muraz
name: Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso
First posted: 2008-05-20
Enrollment: 1370
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment.
timeFrame: Up to delivery
Secondary outcomes:
measure: To determine if the occurrence of malaria during pregnancy influences the incidence of clinical malaria in infants during their first year of life.
timeFrame: Up to one year after delivery
measure: To determine the burden of clinical malaria during pregnancy and its consequences on maternal anaemia, new birth weight and foetal anaemia.
timeFrame: Up to delivery
measure: Effect of standard antimalarial treatment on the selection of resistant parasites in pregnant women under weekly chemoprophylaxis or intermittent treatment.
timeFrame: Up to one year after delivery
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: Centre Muraz
Study officials:
affiliation: Centre Muraz
name: Marie Claire Henry, MD
role: PRINCIPAL_INVESTIGATOR
References: