Preventing Malaria During Pregnancy in Epidemic-prone Areas.
The Efficacy and Cost-effectiveness of Malaria Prevention in Pregnancy in an Area of Low and Unstable Transmission in Kabale, Uganda: Use of Intermittent Preventive Treatment and Insecticide-treated Nets.
1 other identifier
interventional
4,775
1 country
1
Brief Summary
The purpose of this study is to compare the efficacy and cost-effectiveness of three alternative strategies for the prevention of malaria during pregnancy in an epidemic-prone area of low transmission in the East African Highlands. The strategies being compared are:
- intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP)
- an insecticide treated net (ITN), and
- intermittent preventive treatment with SP plus an ITN In addition to the main individually-randomised trial, outcome data was subsequently also gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS) as part of a non-randomised district-wide control programme to compare the impact of IRS with the three intervention arms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2004
Typical duration for phase_3
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
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedJanuary 12, 2017
January 1, 2017
3 years
August 31, 2005
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
mean birthweight
April 2004-Jan 2007
prevalence of low birthweight
April 2004 - Jan 2007
Secondary Outcomes (3)
maternal anaemia - mean Hb at gestational age 36 weeks, prevalence of Hb<100g/L at gestational age 36 weeks
Feb 2003 - Jan 2007
spontaneous abortions
Feb 2003 - Jan 2007
stillbirths
April 2003-Jan 2007
Study Arms (3)
1
ACTIVE COMPARATORDrug: Intermittent preventive treatment:sulphadoxine-pyrimethamine
2
ACTIVE COMPARATORDevice: Insecticide-treated mosquito bed net
3
ACTIVE COMPARATORCombination of Drug + Device: Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine Device: Insecticide-treated mosquito bed net
Interventions
Two doses given twice during pregnancy (once in the second trimester, and once in the third trimester). Oral medication in tablet form: single daily dose given on each occasion
Eligibility Criteria
You may qualify if:
- Pregnant women whose pregnancies are at \<27 weeks gestation at first antenatal booking
- Permanent resident in study area
- Informed consent
You may not qualify if:
- Late presentation: pregnancies more than 26 weeks gestation at first antenatal booking
- Severe anaemia (Hb\<70g/L) on enrolment
- Previous reaction to a sulfa-drug (e.g. sulphadoxine-pyrimethamine, septrin)
- History of severe skin reaction to any drug
- Current (or history) of severe disease (e.g. hepatitis, jaundice, TB, AIDS)
- Withdrawal Criteria:
- Withdrawal of consent
- Women developing severe anaemia (Hb\<70g/L)during pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kabale District Health Services (antenatal clinics at selected sites)
Kabale, Kabale District, Uganda
Related Publications (3)
Ndyomugyenyi R, Clarke S, Chandramohan D, Twesigomwe T & Magnussen P. (2005). Epidemiology of pregnancy-associated malaria in the Ugandan highlands [abstract]. Acta Tropica, Suppl 95: S448.
BACKGROUNDHansen KS, Ndyomugyenyi R, Magnussen P, Clarke SE. Cost-effectiveness analysis of three health interventions to prevent malaria in pregnancy in an area of low transmission in Uganda. Int Health. 2012 Mar;4(1):38-46. doi: 10.1016/j.inhe.2011.10.001.
PMID: 24030879DERIVEDNdyomugyenyi R, Clarke SE, Hutchison CL, Hansen KS, Magnussen P. Efficacy of malaria prevention during pregnancy in an area of low and unstable transmission: an individually-randomised placebo-controlled trial using intermittent preventive treatment and insecticide-treated nets in the Kabale Highlands, southwestern Uganda. Trans R Soc Trop Med Hyg. 2011 Nov;105(11):607-16. doi: 10.1016/j.trstmh.2011.07.012. Epub 2011 Oct 2.
PMID: 21962292DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard H Ndyomugyenyi, MBChB, PhD
Vector Control Division, Ministry of Health, Uganda
- PRINCIPAL INVESTIGATOR
Sian E Clarke, PhD
London School of Hygiene and Tropical Medicine, University of London, UK
- PRINCIPAL INVESTIGATOR
Pascal Magnussen, MD
DBL - Institute for Health Research and Development, Denmark
- PRINCIPAL INVESTIGATOR
Kristian Schultz Hansen, PhD
DBL - Institute for Health Research and Development, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
January 1, 2004
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
January 12, 2017
Record last verified: 2017-01