Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-27 @ 4:05 PM
Study NCT ID:
NCT02981758
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2016-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT)
Sponsor:
Hackensack Meridian Health
Organization:
Study Overview
Official Title:
Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT) - A Retrospective Blinded Cohort Study
Status:
COMPLETED
Status Verified Date:
2020-02
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:
ADOPT
Brief Summary:
A comparison of reported estimated blood loss with quantified blood loss in all patients whose medical records indicate Triton was used during their vaginal delivery.
Detailed Description:
This study is a retrospective blinded cohort trial comprised of two data collection phases. In the first phase data will be collected on all women who had vaginal deliveries between 2010 and 2015 who had a procedure code indicative of transfusion (99.0x) or received a diagnosis suggestive of peripartum hemorrhage (e.g. diagnosis x code 666.xx, 641.x, 645.x, 646.x 674.x). Phase 2 will consist of all women who delivered (vaginally) at HackensackUMC who had blood loss and measured quantitatively by Triton and qualitatively (i.e., EBL) by obstetrician. This will be accomplished by reviewing the records of women who delivered and were discharged within the data collection period.
Study Oversight
Has Oversight DMC:
False
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?: