Navrongo Drug Options for IPT in Pregnancy Trial
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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 |
- HB at delivery [ Time Frame: with inseven 7days of delivery ]
- 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 |
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| Ghana | |
| Navrongo District Hosptial | |
| Navrongo, Upper East Region, 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
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 Sulfadoxine-pyrimethamine 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 May 19, 2013