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Completed

NCT Number: NCT00680732

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

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).

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Key information

Conditions

Malaria Birth Weight Body Weight Infections Malaria in Pregnancy Mosquito-Borne Diseases Parasitic Diseases Pathological Conditions, Signs and Symptoms Protozoan Infections Signs and Symptoms Vector Borne Diseases

Age range

15 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Centre Muraz

Bobo-Dioulasso, BP 390, Burkina Faso

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiple micronutrients supplements (MMS)

Dietary Supplement

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 names: UNIMMAP

Iron and Folic Acid (IFA)

Dietary Supplement

Iron 60 mg and folic acid 400 mcg

Chloroquine (CQ)

Drug

Tablets 100 mg of chloroquine base

Sulphadoxyne-pyrimethamine (SP)

Drug

Tablets

Other names: Fansidar

Primary outcomes

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

    Time frame: Up to delivery

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Centre Muraz
  • Departments of Parasitology and Public Health, ITM, Antwerp, Belgium
  • Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
May 20, 2008
Registry last updated
Sep 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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