Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430398
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-21
Brief Title:
A Novel Multiomic AI Approach for Early Preeclampsia Prediction in Pregnancy
Sponsor:
Organization:
Istituto Clinico Humanitas
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_WITH_DNA
Bio Spec Description:
The protocol involves the analysis of maternal microbiota and metabolome from saliva and fecal samples as well as blood samples collected from consenting women during scheduled obstetric visits conducted by the studys responsible physicians until delivery At each visit as per protocol saliva and fecal samples will be collected and frozen at -80C and a 7 ml whole peripheral blood sample in EDTA will be collected and kept at room temperature The blood will be centrifuged to separate plasma from the cellular fraction The isolated plasma will be frozen at -80C for subsequent metabolomic and microbiota analyses while the cells will be resuspended in phosphate-buffered saline PBS in equal volume to the isolated plasma
Enrollment Count:
600
Enrollment Type:
ESTIMATED
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Case-Control |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 107317 |
Who Masked List: