Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209781
Status:
UNKNOWN
Last Update Posted:
2008-03-06
First Post:
2005-09-13
Brief Title:
IPTp Plus ITNs for Malaria Control in Pregnant Women
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Effect of Intermittent Preventive Treatment IPTp With Sulfadoxine-Pyrimethamine Plus Insecticide Treated Nets Delivered Through Antenatal Clinics for the Prevention of Malaria in Mozambican Pregnant Women
Status:
UNKNOWN
Status Verified Date:
2008-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
We aim to evaluate whether IPT in pregnancy provides any additional benefit to the protection afforded by ITNs
Detailed Description:
Pregnant women are at an increased risk for malaria infection and disease Maternal anaemia low birth weight and prematurity are the most frequent adverse effects of the infection The current WHO recommendation consists on the provision of insecticide treated nets ITNs and intermittent preventive treatment IPT Results from a recentn trial of ITNs have shown a significant reduction in maternal anaemia parasitaemia and low birth weight prevalence in women sleeping under impregnated nets However scarce information exists on the relative efficacy of IPT and ITNs to reduce the deleterious effects of malaria infection during pregnancy when given at the same time This information is of relevance to guide national malaria control programmes
This study consists on the administration of two double blind doses of IPT with Sulfadoxine-Pyrimethamine or placebo at predefined intervals after the beginning of the second trimester All women receive an ITN
This study consists on the administration of two double blind doses of IPT with Sulfadoxine-Pyrimethamine or placebo at predefined intervals after the beginning of the second trimester All women receive an ITN
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