Navrongo Drug Options for IPT in Pregnancy Trial
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
1 other identifier
interventional
3,642
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 5, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedJanuary 12, 2017
January 1, 2017
September 5, 2005
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HB at delivery
with inseven 7days of delivery
Secondary Outcomes (4)
placental malaria
on the day of delivery
maternal peripheral parasitaemia at delivery
within seven days of dellivery
tolerance and adverse events after taking study drugs
molecular markers of drug resistance to SP and Amodiaquine
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Navrongo District Hosptial
Navrongo, Upper East Region, Ghana
Related Publications (1)
Clerk CA, Bruce J, Affipunguh PK, Mensah N, Hodgson A, Greenwood B, Chandramohan D. A randomized, controlled trial of intermittent preventive treatment with sulfadoxine-pyrimethamine, amodiaquine, or the combination in pregnant women in Ghana. J Infect Dis. 2008 Oct 15;198(8):1202-11. doi: 10.1086/591944.
PMID: 18752443DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 5, 2005
First Posted
September 7, 2005
Study Start
June 1, 2004
Study Completion
February 1, 2007
Last Updated
January 12, 2017
Record last verified: 2017-01