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Clinical Trials/NCT00140517
NCT00140517CompletedNot Applicable

Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance

London School of Hygiene and Tropical Medicine2 sites in 1 country700 target enrollmentStarted: October 2002Last updated:
Conditions
Drugs

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brian Greenwood

Professor

London School of Hygiene and Tropical Medicine

Study Sites (2)

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