Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT)

Completed

• Conditions: Post-partum Hemorrhage (PPH)

• Registration Number: NCT02981758
• Lead Sponsor: Hackensack Meridian Health

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-11-18
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-05
• Primary Completion: 2018-07
• Study Completion: 2019-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• All women who delivered (vaginally) at HackensackUMC who had blood loss and measured quantitatively by Triton and qualitatively (i.e., EBL) by obstetrician.
• All women who had vaginal deliveries between 2010 and 2015 at HackensackUMC 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).

Exclusion Criteria

• Women who received transfusions unrelated directly to pregnancy (e.g. renal disease, anemia of pregnancy, genetic or viral conditions causing anemia).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantification of blood loss during vaginal deliveries	During immediate postpartum period.	Retrospective Chart Review of blood loss during delivery

Secondary Outcome Measures

Name	Time	Method
Comparison of quantified blood loss (hemoglobin loss) using the The Triton™	During immediate postpartum period.	Retrospective Chart Review of blood loss during delivery
Comparison of quantified blood loss (hemoglobin loss) using the The Triton™ System of mobile imaging with computer vision and learning algorithms compared to estimations of blood loss given by the provider.	During labor	Retrospective Chart Review of blood loss during delivery

Trial Locations

Locations (1)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States