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Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT) (ADOPT)

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ClinicalTrials.gov Identifier: NCT02981758
Recruitment Status : Active, not recruiting
First Posted : December 5, 2016
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Post-partum Hemorrhage (PPH)

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.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT) - A Retrospective Blinded Cohort Study
Study Start Date : July 2016
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Data Collection Phase 1
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
All women who delivered (vaginally) at HackensackUMC who had blood loss and measured quantitatively by Triton and qualitatively (i.e., EBL) by obstetrician.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981758


Locations
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United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack Meridian Health
Investigators
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Principal Investigator: Andrew Rubenstein, M.D. Hackensack Meridian Health

Publications of Results:
Centers for Disease Control and Prevention Mortality Data Run (November 17, 2015)
Royal College of Obstetrician and Gynaecologists. (2011). Postpartum hemorrhage: prevention and management. Retrieved May2, 2016 from http://www.cedepap.tv/GPC17.pdf
The Joint Commission. (2010) Preventing maternal death. Sentinel Event Alert, 44, 1-4. Retrieved from http://www.jointcommission. org/assets/1/18/SEA_44.PDF
WHO. Trends in maternal mortality 1990 -2008 estimates developed by WHO, UNICEF, UNFPA and The World Bank, World Health Organization 2010 Annex 1 http://whsqibdoc.who.int/publications2010/9789241500265

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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT02981758     History of Changes
Other Study ID Numbers: Pro2016-0184
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage