Navrongo Drug Options for IPT in Pregnancy Trial

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Ghana
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00146783
First received: September 5, 2005
Last updated: February 7, 2008
Last verified: February 2008
  Purpose

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 Intervention Phase
Malaria
Drug: Sulphadoxine-pyrimethamine
Drug: Sulphadoxine-pyrimethamine, amodiaquine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

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

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

Enrollment: 3642
Study Start Date: June 2004
Study Completion Date: February 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146783

Locations
Ghana
Navrongo District Hosptial
Navrongo, Upper East Region, Ghana
Sponsors and Collaborators
Gates Malaria Partnership
Ministry of Health, Ghana
Investigators
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

No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00146783     History of Changes
Other Study ID Numbers: ITCR5096
Study First Received: September 5, 2005
Last Updated: February 7, 2008
Health Authority: Ghana: Ministry of Health

Keywords provided by Gates Malaria Partnership:
intermittent preventive treatment
malaria
pregnancy
efficacy
safety

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Amodiaquine
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on August 20, 2014