Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06168019
Status:
RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-12-12
Brief Title:
Influenza COVID-19 Obstetric and Perinatal Epidemiology Study in India
Sponsor:
Organization:
Boston University
Study Design
Study Type:
OBSERVATIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
False
Target Duration:
None
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
SAMPLES_WITHOUT_DNA
Bio Spec Description:
Blood samples for COVID-19 influenza and ORV antibodies and potential modifiers of infection will be drawn at a maximum of four time points - baseline week 6-13 of pregnancy at study visit 3 week 28-34 at study visit 4 week 37-prior to delivery of pregnancy and between delivery and day 42-70 postpartumafter miscarriage In addition a random subset of 200 subjects will be invited to provide nasopharyngeal NPswabs during all 4 study visits and between delivery and day 7 postpartum prior to discharge to track asymptomatic viral infection
Enrollment Count:
10000
Enrollment Type:
ESTIMATED
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Cohort |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 101592 |
Who Masked List: