Clinical trial NCT02981758: Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT)
Official title: Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT) - A Retrospective Blinded Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-partum Hemorrhage (PPH)
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women who delivered (vaginally) at HackensackUMC between 2010 and 2015 who had blood loss during the delivery.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Quantification of blood loss during vaginal deliveries
timeFrame: During labor
measure: Quantification of blood loss during vaginal deliveries
timeFrame: During delivery (intrapartum)
measure: Quantification of blood loss during vaginal deliveries
timeFrame: During immediate postpartum period.
Secondary outcomes:
measure: 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.
timeFrame: During labor
measure: Comparison of quantified blood loss (hemoglobin loss) using the The Triton™
timeFrame: During delivery (intrapartum)
measure: Comparison of quantified blood loss (hemoglobin loss) using the The Triton™
timeFrame: During immediate postpartum period.
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Andrew Rubenstein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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