Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468319
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-05-28
Brief Title:
Pregnancy Registry in Mali
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Assessment of Pregnancy Outcomes Through Demographic Surveillance and Prospective Data Collection at a Health Facility in Kalifabougou Mali
Status:
RECRUITING
Status Verified Date:
2024-08
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:
This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou Mali
Detailed Description:
This pregnancy registry will gather background data on pregnancy rates and outcomes as well as infant health data to inform future implementation of clinical trials testing monoclonal antibodies mAbs to prevent malaria in pregnancy
In the first part of the study Community Census Cohort women of child-bearing age WOCBA in the community will be identified and followed for up to 3 years to detect pregnancy at all stages Upon detection of pregnancy these women may then transition to participation in the Health Facility Cohort
In the second part of the study Health Facility Cohort data will be prospectively collected from pregnant women presenting at the health facility for antenatal care ANC visits or referred in from the Community Census Cohort The pregnant women will be followed through pregnancy outcome and until 12 months postpartum and their infants will be followed until 12 months of age
The study team will collect baseline information in a systematic manner on early pregnancy events pregnancy and postpartum complications and outcomes utilization of existing malaria prevention tools malaria infections and clinical disease birth outcomes and follow-up of subsequent offspring
In the first part of the study Community Census Cohort women of child-bearing age WOCBA in the community will be identified and followed for up to 3 years to detect pregnancy at all stages Upon detection of pregnancy these women may then transition to participation in the Health Facility Cohort
In the second part of the study Health Facility Cohort data will be prospectively collected from pregnant women presenting at the health facility for antenatal care ANC visits or referred in from the Community Census Cohort The pregnant women will be followed through pregnancy outcome and until 12 months postpartum and their infants will be followed until 12 months of age
The study team will collect baseline information in a systematic manner on early pregnancy events pregnancy and postpartum complications and outcomes utilization of existing malaria prevention tools malaria infections and clinical disease birth outcomes and follow-up of subsequent offspring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None