Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142207
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-08-31
Brief Title:
Preventing Malaria During Pregnancy in Epidemic-prone Areas
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Susceptibility to malaria infection during pregnancy and the severity of clinical manifestation are determined by the level of pre-pregnancy immunity which depends on intensity and stability of malaria transmission Most intervention trials to prevent malaria during pregnancy have been conducted in areas of intense transmission The results of trials conducted in high-transmission areas may not be applicable to low transmission areas where malaria is less frequent but the risk of spontaneous abortion and stillbirth is very high in women of all parities due to lack of sufficient malaria immunity Routine chemoprophylaxis is generally not recommended in areas of unstable malaria transmission However intermittent treatment with an effective anti-malarial drug may be beneficial especially during periods of malaria transmission Little work has been carried out amongst pregnant women living in areas of low and unstable transmission in Africa No data are available on the cost-effectiveness of malaria control in low transmission settings
This study will compare the efficacy and cost effectiveness of three preventive strategies for the control of malaria during pregnancy in low-transmission settings The study is located in Kabale district a highland area in SW Uganda
Women attending antenatal care are randomised to receive either
intermittent preventive treatment with sulfadoxine-pyrimethamine IPT-SP
an insecticide treated net ITN or
intermittent preventive treatment with SP and an ITN It is hypothesized that when combined with IPT-SP the additional impact of ITNs by reducing exposure may be greatest where the intensity of transmission is low
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
The study aims to identify the most effective intervention strategies suited to areas characterised by low and unstable transmission Research findings should be applicable to other hypoendemic areas of the East African highlands
This study will compare the efficacy and cost effectiveness of three preventive strategies for the control of malaria during pregnancy in low-transmission settings The study is located in Kabale district a highland area in SW Uganda
Women attending antenatal care are randomised to receive either
intermittent preventive treatment with sulfadoxine-pyrimethamine IPT-SP
an insecticide treated net ITN or
intermittent preventive treatment with SP and an ITN It is hypothesized that when combined with IPT-SP the additional impact of ITNs by reducing exposure may be greatest where the intensity of transmission is low
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
The study aims to identify the most effective intervention strategies suited to areas characterised by low and unstable transmission Research findings should be applicable to other hypoendemic areas of the East African highlands
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None