Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148629
Status:
UNKNOWN
Last Update Posted:
2022-02-08
First Post:
2005-09-06
Brief Title:
Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women
Sponsor:
Cornell University
Organization:
Cornell University
Study Overview
Official Title:
Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care
Status:
UNKNOWN
Status Verified Date:
2022-01
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:
The purpose of this research is to compare the efficacy of two low-cost low intervention packages to prevent and treat severe anemia in pregnant women in Zanzibar Tanzania The two packages are Standard of Care as described by the WHO presumptive treatment for malaria and helminths plus daily iron folic acid supplements and Enhanced Care Standard of Care plus daily multivitamins and a 2nd dose of anthelminthic
Detailed Description:
This is a clinic-randomized trial involving 8 antenatal clinics and approximately 2500 women The specific aims are
Aim 1 To evaluate the efficacy of the current internationally recommended standard of care as described by the WHO for the prevention of severe anemia among pregnant Zanzibari women This aim will be achieved through a pre-post intervention comparison
Aim 2 To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to prevent severe anemia among pregnant Zanzibari women
Aim 3 To evaluate the efficacy of the current internationally recommended standard of care as described by the WHO for the cure of severe anemia among pregnant Zanzibari women
Aim 4 To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to cure severe anemia among pregnant Zanzibari women
Aim 1 To evaluate the efficacy of the current internationally recommended standard of care as described by the WHO for the prevention of severe anemia among pregnant Zanzibari women This aim will be achieved through a pre-post intervention comparison
Aim 2 To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to prevent severe anemia among pregnant Zanzibari women
Aim 3 To evaluate the efficacy of the current internationally recommended standard of care as described by the WHO for the cure of severe anemia among pregnant Zanzibari women
Aim 4 To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to cure severe anemia among pregnant Zanzibari women
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