Efficacy and Safety of Sulphadoxine-pyrimethamine and Amodiaquine in Ghanaian Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00131703
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : January 12, 2017
Ministry of Health, Ghana
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine

Brief Summary:
Malaria in pregnancy is potentially fatal to both the mother and the foetus particularly in the primigravidae. Implementation of appropriate control and preventive measures is challenged by the fact that malaria infection in pregnancy is often asymptomatic and parasitized red blood cells sequestrated in the placental microcirculation may not be detectable in the peripheral blood. In addition, the widespread prevalence of parasites resistant to chloroquine and sulphadoxine-pyrimethamine (SP) and, the safety concerns about newer antimalarials, poverty and inadequate supply have made antimalarial treatment options available to pregnant women very limited. These have necessitated an urgent search for alternative safe and efficacious treatment options for pregnant women. The objective of this study is to assess the efficacy, safety and tolerability of four antimalarial treatment options in rural Ghana within a programme setting.

Condition or disease Intervention/treatment Phase
Malaria Pregnancy Drug: Amodiaquine Drug: Sulphadoxine-pyrimethamine Drug: Chloroquine Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised Double Blind Clinical Trial of Amodiaquine (AQ) and Sulphadoxine-pyrimethamine (SP) Used Singly and in Combination (AQ+SP) Compared With Chloroquine (CQ) in the Treatment of Falciparum Malaria Infection in Pregnancy
Study Start Date : March 2003
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Primary Outcome Measures :
  1. Prevalence of parasitaemia on day 28 post treatment.
  2. Prevalence of parasitaemia on day 14 post treatment.

Secondary Outcome Measures :
  1. Incidence of adverse drug events within seven days following treatment.
  2. Proportions of pregnant women withdrawn from the study due to the occurrence of adverse drug events (clinical and laboratory) by day 7 following initiation of treatment.
  3. Change in maternal haemoglobin concentrations at days 14 and 28 following treatment.
  4. Prevalence of peripheral parasitaemia at delivery.
  5. Prevalence of placental parasitaemia at delivery.
  6. Proportions of abnormal biochemistry and white blood cell values on days 14 and 28 post treatment.
  7. Sensitivity, specificity, positive and negative predictive values, likelihood ratios, and the area under receiver operating characteristic (ROC) curve for the OptiMAL antigen test.
  8. Incidences of adverse pregnancy outcomes in the study group.
  9. Prevalence of postpartum parasitaemia.
  10. Prevalence of postpartum anaemia.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Gestational age of at least 16 weeks.
  • P. falciparum parasitaemia of any density with or without symptoms.
  • Informed consent.
  • No known adverse reaction to any of the study drugs.
  • Residence in the study area.

Exclusion Criteria:

  • Past obstetric and medical history that might adversely affect the interpretation of outcomes such as repeated stillbirths and eclampsia.
  • History of severe adverse drug reactions to co-trimoxazole in the past.
  • Haemoglobin concentration below 5.0 g/dl.
  • Severe malaria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00131703

Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Ministry of Health, Ghana
Principal Investigator: Harry K Tagbor, MD London School of Hygiene and Tropical Medicine

Publications of Results:
Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine Identifier: NCT00131703     History of Changes
Other Study ID Numbers: ITCR5092
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
Malaria in pregnancy

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Chloroquine diphosphate
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antinematodal Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents