Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT) - A Retrospective Blinded Cohort Study

Conditions
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Post-partum Hemorrhage (PPH)

Participation Criteria
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Eligibility Criteria
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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).
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Data Collection Phase 1<br>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). | |
| Data Collection Phase 2<br>All women who delivered (vaginally) at HackensackUMC who had blood loss and measured quantitatively by Triton and qualitatively (i.e., EBL) by obstetrician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of blood loss during vaginal deliveries | Retrospective Chart Review of blood loss during delivery | During labor | 
| Quantification of blood loss during vaginal deliveries | Retrospective Chart Review of blood loss during delivery | During delivery (intrapartum) | 
| Quantification of blood loss during vaginal deliveries | Retrospective Chart Review of blood loss during delivery | During immediate postpartum period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Retrospective Chart Review of blood loss during delivery | During labor | 
| Comparison of quantified blood loss (hemoglobin loss) using the The Triton™ | Retrospective Chart Review of blood loss during delivery | During delivery (intrapartum) | 
| Comparison of quantified blood loss (hemoglobin loss) using the The Triton™ | Retrospective Chart Review of blood loss during delivery | During immediate postpartum period. |