Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 700
- Locations
- 2
- Primary Endpoint
- See detailed description
Study Overview
Brief Summary
Plasmodium falciparum resistance to chloroquine (CQ) and sulfadoxine-pyrimethamine (SP) continue to spread, impeding control of this important disease. CQ and SP are still the most commonly used antimalarial drugs for malaria prevention during pregnancy and might be made less effective by resistance. However, the treatment and prophylaxis regimens used may also create conditions for selecting resistant malaria parasite strains. A better understanding of the relationships between chemoprophylaxis regimens and resistance would be helpful to improve chemoprophylaxis of malaria in pregnancy.
This work aims to improve the use of chemoprophylaxis in pregnancy by determining whether there is a relationship between the use of standard prophylactic regimens with CQ and SP and the occurrence of P. falciparum resistant strains in pregnant women. The study consists of 2 parts. The first part is a randomized trial comparing 3 chemoprophylactic treatment groups: - weekly CQ after initial presumptive CQ treatment, - CQ intermittent presumptive treatment given as a standard dose at 2nd and 3rd trimester, respectively and SP intermittent presumptive treatment given as a single dose at 2nd and 3rd trimester, respectively. These treatment groups will also be compared to a group of women delivering at the same health centre but who have not been participating in the study. The second part will be a clinical trial for assessment of clinical and parasitological efficacy of CQ and SP treatment in pregnant women presenting with uncomplicated malaria attacks.
The study will be conducted from October 2002 to March 2005 in a health centre of Ouagadougou, Burkina Faso where malaria transmission is seasonal and resistance to CQ and SP is low.
Detailed Description
OBJECTIVES Overall objective: To improve the use of malaria chemoprophylaxis in pregnancy.
Specific objectives:
To investigate the effects of weekly CQ, intermittent presumptive treatment with CQ, and with SP on placental, peripheral, and cord parasitaemia and on P. falciparum resistance status in primigravidae and secundigravidae.
To determine the relationships between carriage of P. falciparum resistant strains and malaria morbidity (attacks and anaemia) during pregnancy.
To determine the clinical and parasitological efficacy of CQ and SP in primigravidae and secundigravidae.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 15 Years to 49 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •primi or secundigravidae - seen between 12th and 24th weeks of gestation
- •with a non 'at risk pregnancy' (multiple pregnancy, obstetric misproportions, previous caesarean, high blood pressure, diabetes, clinical signs of AIDS.
- •staying in a neighbouring district or village
- •ability to come for follow-up and delivery.
Exclusion Criteria
- •• At risk pregnancy
- •Severe systemic disease
- •Wish to withdraw from participation.
Outcomes
Primary Outcomes
See detailed description
Secondary Outcomes
- see detailed description
Investigators
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine
