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Completed

NCT Number: NCT02981758

Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT)

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Quantification of blood loss during vaginal deliveries

    Time frame: During labor

    Retrospective Chart Review of blood loss during delivery

  2. Quantification of blood loss during vaginal deliveries

    Time frame: During delivery (intrapartum)

    Retrospective Chart Review of blood loss during delivery

  3. Quantification of blood loss during vaginal deliveries

    Time frame: During immediate postpartum period.

    Retrospective Chart Review of blood loss during delivery

Secondary outcomes

  1. 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.

    Time frame: During labor

    Retrospective Chart Review of blood loss during delivery

  2. Comparison of quantified blood loss (hemoglobin loss) using the The Triton™

    Time frame: During delivery (intrapartum)

    Retrospective Chart Review of blood loss during delivery

  3. Comparison of quantified blood loss (hemoglobin loss) using the The Triton™

    Time frame: During immediate postpartum period.

    Retrospective Chart Review of blood loss during delivery

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Registry information

Official study title

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

Acronym: ADOPT

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Dec 5, 2016
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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