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Navrongo Drug Options for IPT in Pregnancy Trial

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.
ClinicalTrials.gov Identifier: NCT00146783
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : January 12, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
In areas of stable transmission, pregnant women, especially during the first and second pregnancies, have an increased susceptibility to Plasmodium falciparum malaria, malaria-related anaemia and an increased risk of having low birthweight babies. Intermittent Preventive Treatment in pregnancy(IPTp) with sulphadoxine-pyrimethamine has been shown to be effective in reducing the effects of malaria in pregnancy. This has mainly been in areas of perennial transmission and there is a need to study this effect in intense seasonal transmission settings. The emergence and spread of resistance to SP is likely to undermine its useful lifespan and it is important that other antimalarials that are safe and effective are identified for use in IPTp. The options are however limited. Amodiaquine has been shown to be effective in treatment of clinical cases of malaria, even in areas where chloroquine resistance is prevalent, and its combination with SP has been associated with favourable results. Both are affordable. However, there is limited data on their use in pregnancy. This study aims to assess the efficacy of SP in an area of intense seasonal transmission, and evaluate the safety and efficacy of amodiaquine and a combination of sulphadoxine-pyrimethamine and amodiaquine as possible alternatives to SP for use as IPTp.

Condition or disease Intervention/treatment Phase
Malaria Drug: Sulphadoxine-pyrimethamine Drug: Sulphadoxine-pyrimethamine, amodiaquine Phase 2 Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3642 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Efficacy of Sulphadoxine-pyrimethamine and Amodiaquine Alone or in Combination as Intermittent Preventive Treatment in Pregnancy in the Kassena-Nankana District of Ghana: a Randomized Controlled Trial
Study Start Date : June 2004
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. HB at delivery [ Time Frame: with inseven 7days of delivery ]

Secondary Outcome Measures :
  1. placental malaria [ Time Frame: on the day of delivery ]
  2. maternal peripheral parasitaemia at delivery [ Time Frame: within seven days of dellivery ]
  3. tolerance and adverse events after taking study drugs
  4. molecular markers of drug resistance to SP and Amodiaquine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pregnant women with gestation between 18-32weeks,
  • willing to give written consent to take part in the study
  • Resident in the study area and available for follow-up.

Exclusion Criteria:

  • Presentation with clinical symptoms of malaria (this would not affect subsequent enrollment at a later date),
  • Known allergies or reactions to study drugs,
  • Medical conditions needing hospital admission.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00146783

Navrongo District Hosptial
Navrongo, Upper East Region, Ghana
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Ministry of Health, Ghana
Principal Investigator: Christine Clerk, MBChB, MSc London School of Hygiene and Tropical Medicine
Principal Investigator: Daniel Chandramohan, MBBS, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Brian Greenwood, FRCP, FRS London School of Hygiene and Tropical Medicine
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00146783     History of Changes
Other Study ID Numbers: ITCR5096
First Posted: September 7, 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:
intermittent preventive treatment

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents