<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02981758</url>
  </required_header>
  <id_info>
    <org_study_id>Pro2016-0184</org_study_id>
    <nct_id>NCT02981758</nct_id>
  </id_info>
  <brief_title>Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT)</brief_title>
  <acronym>ADOPT</acronym>
  <official_title>Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT) - A Retrospective Blinded Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hackensack Meridian Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hackensack Meridian Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A comparison of reported estimated blood loss with quantified blood loss in all patients&#xD;
      whose medical records indicate Triton was used during their vaginal delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a retrospective blinded cohort trial comprised of two data collection phases.&#xD;
      In the first phase data will be collected on all women who had vaginal deliveries between&#xD;
      2010 and 2015 who had a procedure code indicative of transfusion (99.0x) or received a&#xD;
      diagnosis suggestive of peripartum hemorrhage (e.g. diagnosis x code 666.xx, 641.x, 645.x,&#xD;
      646.x 674.x). Phase 2 will consist of all women who delivered (vaginally) at HackensackUMC&#xD;
      who had blood loss and measured quantitatively by Triton and qualitatively (i.e., EBL) by&#xD;
      obstetrician. This will be accomplished by reviewing the records of women who delivered and&#xD;
      were discharged within the data collection period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quantification of blood loss during vaginal deliveries</measure>
    <time_frame>During labor</time_frame>
    <description>Retrospective Chart Review of blood loss during delivery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantification of blood loss during vaginal deliveries</measure>
    <time_frame>During delivery (intrapartum)</time_frame>
    <description>Retrospective Chart Review of blood loss during delivery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantification of blood loss during vaginal deliveries</measure>
    <time_frame>During immediate postpartum period.</time_frame>
    <description>Retrospective Chart Review of blood loss during delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <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.</measure>
    <time_frame>During labor</time_frame>
    <description>Retrospective Chart Review of blood loss during delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of quantified blood loss (hemoglobin loss) using the The Triton™</measure>
    <time_frame>During delivery (intrapartum)</time_frame>
    <description>Retrospective Chart Review of blood loss during delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of quantified blood loss (hemoglobin loss) using the The Triton™</measure>
    <time_frame>During immediate postpartum period.</time_frame>
    <description>Retrospective Chart Review of blood loss during delivery</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Post-partum Hemorrhage (PPH)</condition>
  <arm_group>
    <arm_group_label>Data Collection Phase 1</arm_group_label>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Data Collection Phase 2</arm_group_label>
    <description>All women who delivered (vaginally) at HackensackUMC who had blood loss and measured quantitatively by Triton and qualitatively (i.e., EBL) by obstetrician.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All women who delivered (vaginally) at HackensackUMC between 2010 and 2015 who had blood&#xD;
        loss during the delivery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All women who delivered (vaginally) at HackensackUMC who had blood loss and measured&#xD;
             quantitatively by Triton and qualitatively (i.e., EBL) by obstetrician.&#xD;
&#xD;
          -  All women who had vaginal deliveries between 2010 and 2015 at HackensackUMC who had a&#xD;
             procedure code indicative of transfusion (99.0x) or received a diagnosis suggestive of&#xD;
             peripartum hemorrhage (e.g. diagnosis x code 666.xx, 641.x, 645.x, 646.x 674.x).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who received transfusions unrelated directly to pregnancy (e.g. renal disease,&#xD;
             anemia of pregnancy, genetic or viral conditions causing anemia).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Rubenstein, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hackensack Meridian Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Al Kadri HM, Al Anazi BK, Tamim HM. Visual estimation versus gravimetric measurement of postpartum blood loss: a prospective cohort study. Arch Gynecol Obstet. 2011 Jun;283(6):1207-13. doi: 10.1007/s00404-010-1522-1. Epub 2010 May 28.</citation>
    <PMID>20508942</PMID>
  </results_reference>
  <results_reference>
    <citation>Berg CJ, Harper MA, Atkinson SM, Bell EA, Brown HL, Hage ML, Mitra AG, Moise KJ Jr, Callaghan WM. Preventability of pregnancy-related deaths: results of a state-wide review. Obstet Gynecol. 2005 Dec;106(6):1228-34. doi: 10.1097/01.AOG.0000187894.71913.e8.</citation>
    <PMID>16319245</PMID>
  </results_reference>
  <results_reference>
    <citation>Brant HA. Precise estimation of postpartum haemorrhage: difficulties and importance. Br Med J. 1967 Feb 18;1(5537):398-400. doi: 10.1136/bmj.1.5537.398. No abstract available.</citation>
    <PMID>5297397</PMID>
  </results_reference>
  <results_reference>
    <citation>Calvert C, Thomas SL, Ronsmans C, Wagner KS, Adler AJ, Filippi V. Identifying regional variation in the prevalence of postpartum haemorrhage: a systematic review and meta-analysis. PLoS One. 2012;7(7):e41114. doi: 10.1371/journal.pone.0041114. Epub 2012 Jul 23.</citation>
    <PMID>22844432</PMID>
  </results_reference>
  <results_reference>
    <citation>Centers for Disease Control and Prevention Mortality Data Run (November 17, 2015)</citation>
  </results_reference>
  <results_reference>
    <citation>D'Alton ME, Main EK, Menard MK, Levy BS. The National Partnership for Maternal Safety. Obstet Gynecol. 2014 May;123(5):973-977. doi: 10.1097/AOG.0000000000000219.</citation>
    <PMID>24785848</PMID>
  </results_reference>
  <results_reference>
    <citation>Della Torre M, Kilpatrick SJ, Hibbard JU, Simonson L, Scott S, Koch A, Schy D, Geller SE. Assessing preventability for obstetric hemorrhage. Am J Perinatol. 2011 Dec;28(10):753-60. doi: 10.1055/s-0031-1280856. Epub 2011 Jun 22.</citation>
    <PMID>21698554</PMID>
  </results_reference>
  <results_reference>
    <citation>Dildy GA 3rd, Paine AR, George NC, Velasco C. Estimating blood loss: can teaching significantly improve visual estimation? Obstet Gynecol. 2004 Sep;104(3):601-6. doi: 10.1097/01.AOG.0000137873.07820.34.</citation>
    <PMID>15339775</PMID>
  </results_reference>
  <results_reference>
    <citation>Duthie SJ, Ven D, Yung GL, Guang DZ, Chan SY, Ma HK. Discrepancy between laboratory determination and visual estimation of blood loss during normal delivery. Eur J Obstet Gynecol Reprod Biol. 1991 Jan 30;38(2):119-24. doi: 10.1016/0028-2243(91)90188-q.</citation>
    <PMID>1995380</PMID>
  </results_reference>
  <results_reference>
    <citation>Knight M, Callaghan WM, Berg C, Alexander S, Bouvier-Colle MH, Ford JB, Joseph KS, Lewis G, Liston RM, Roberts CL, Oats J, Walker J. Trends in postpartum hemorrhage in high resource countries: a review and recommendations from the International Postpartum Hemorrhage Collaborative Group. BMC Pregnancy Childbirth. 2009 Nov 27;9:55. doi: 10.1186/1471-2393-9-55.</citation>
    <PMID>19943928</PMID>
  </results_reference>
  <results_reference>
    <citation>Patel A, Goudar SS, Geller SE, Kodkany BS, Edlavitch SA, Wagh K, Patted SS, Naik VA, Moss N, Derman RJ. Drape estimation vs. visual assessment for estimating postpartum hemorrhage. Int J Gynaecol Obstet. 2006 Jun;93(3):220-4. doi: 10.1016/j.ijgo.2006.02.014. Epub 2006 Apr 12. Erratum In: Int J Gynaecol Obstet. 2006 Dec;95(3):312.</citation>
    <PMID>16626718</PMID>
  </results_reference>
  <results_reference>
    <citation>PRITCHARD JA. CHANGES IN THE BLOOD VOLUME DURING PREGNANCY AND DELIVERY. Anesthesiology. 1965 Jul-Aug;26:393-9. doi: 10.1097/00000542-196507000-00004. No abstract available.</citation>
    <PMID>14313451</PMID>
  </results_reference>
  <results_reference>
    <citation>Rath WH. Postpartum hemorrhage--update on problems of definitions and diagnosis. Acta Obstet Gynecol Scand. 2011 May;90(5):421-8. doi: 10.1111/j.1600-0412.2011.01107.x.</citation>
    <PMID>21332452</PMID>
  </results_reference>
  <results_reference>
    <citation>Royal College of Obstetrician and Gynaecologists. (2011). Postpartum hemorrhage: prevention and management. Retrieved May2, 2016 from http://www.cedepap.tv/GPC17.pdf</citation>
  </results_reference>
  <results_reference>
    <citation>Schorn MN. Measurement of blood loss: review of the literature. J Midwifery Womens Health. 2010 Jan-Feb;55(1):20-7. doi: 10.1016/j.jmwh.2009.02.014.</citation>
    <PMID>20129226</PMID>
  </results_reference>
  <results_reference>
    <citation>Stafford I, Dildy GA, Clark SL, Belfort MA. Visually estimated and calculated blood loss in vaginal and cesarean delivery. Am J Obstet Gynecol. 2008 Nov;199(5):519.e1-7. doi: 10.1016/j.ajog.2008.04.049. Epub 2008 Jul 17.</citation>
    <PMID>18639209</PMID>
  </results_reference>
  <results_reference>
    <citation>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</citation>
  </results_reference>
  <results_reference>
    <citation>Toledo P, McCarthy RJ, Hewlett BJ, Fitzgerald PC, Wong CA. The accuracy of blood loss estimation after simulated vaginal delivery. Anesth Analg. 2007 Dec;105(6):1736-40, table of contents. doi: 10.1213/01.ane.0000286233.48111.d8.</citation>
    <PMID>18042876</PMID>
  </results_reference>
  <results_reference>
    <citation>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</citation>
  </results_reference>
  <results_reference>
    <citation>Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011 Jan;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a. No abstract available.</citation>
    <PMID>21173639</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>February 10, 2020</last_update_submitted>
  <last_update_submitted_qc>February 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02981758
org study id: Pro2016-0184
nct id: NCT02981758
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: Quantification of blood loss during vaginal deliveries
time frame: During labor
description: Retrospective Chart Review of blood loss during delivery
measure: Quantification of blood loss during vaginal deliveries
time frame: During delivery (intrapartum)
description: Retrospective Chart Review of blood loss during delivery
measure: Quantification of blood loss during vaginal deliveries
time frame: During immediate postpartum period.
description: Retrospective Chart Review of blood loss during delivery
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.
time frame: During labor
description: Retrospective Chart Review of blood loss during delivery
measure: Comparison of quantified blood loss (hemoglobin loss) using the The Triton™
time frame: During delivery (intrapartum)
description: Retrospective Chart Review of blood loss during delivery
measure: Comparison of quantified blood loss (hemoglobin loss) using the The Triton™
time frame: During immediate postpartum period.
description: Retrospective Chart Review of blood loss during delivery
arm group label: Data Collection Phase 1
description: 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).
arm group label: Data Collection Phase 2
description: All women who delivered (vaginally) at HackensackUMC who had blood loss and measured quantitatively by Triton and qualitatively (i.e., EBL) by obstetrician.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Andrew Rubenstein, M.D.
role: Principal Investigator
affiliation: Hackensack Meridian Health
facility: 
country: United States
citation: Al Kadri HM, Al Anazi BK, Tamim HM. Visual estimation versus gravimetric measurement of postpartum blood loss: a prospective cohort study. Arch Gynecol Obstet. 2011 Jun;283(6):1207-13. doi: 10.1007/s00404-010-1522-1. Epub 2010 May 28.
PMID: 20508942
citation: Berg CJ, Harper MA, Atkinson SM, Bell EA, Brown HL, Hage ML, Mitra AG, Moise KJ Jr, Callaghan WM. Preventability of pregnancy-related deaths: results of a state-wide review. Obstet Gynecol. 2005 Dec;106(6):1228-34. doi: 10.1097/01.AOG.0000187894.71913.e8.
PMID: 16319245
citation: Brant HA. Precise estimation of postpartum haemorrhage: difficulties and importance. Br Med J. 1967 Feb 18;1(5537):398-400. doi: 10.1136/bmj.1.5537.398. No abstract available.
PMID: 5297397
citation: Calvert C, Thomas SL, Ronsmans C, Wagner KS, Adler AJ, Filippi V. Identifying regional variation in the prevalence of postpartum haemorrhage: a systematic review and meta-analysis. PLoS One. 2012;7(7):e41114. doi: 10.1371/journal.pone.0041114. Epub 2012 Jul 23.
PMID: 22844432
citation: Centers for Disease Control and Prevention Mortality Data Run (November 17, 2015)
citation: D'Alton ME, Main EK, Menard MK, Levy BS. The National Partnership for Maternal Safety. Obstet Gynecol. 2014 May;123(5):973-977. doi: 10.1097/AOG.0000000000000219.
PMID: 24785848
citation: Della Torre M, Kilpatrick SJ, Hibbard JU, Simonson L, Scott S, Koch A, Schy D, Geller SE. Assessing preventability for obstetric hemorrhage. Am J Perinatol. 2011 Dec;28(10):753-60. doi: 10.1055/s-0031-1280856. Epub 2011 Jun 22.
PMID: 21698554
citation: Dildy GA 3rd, Paine AR, George NC, Velasco C. Estimating blood loss: can teaching significantly improve visual estimation? Obstet Gynecol. 2004 Sep;104(3):601-6. doi: 10.1097/01.AOG.0000137873.07820.34.
PMID: 15339775
citation: Duthie SJ, Ven D, Yung GL, Guang DZ, Chan SY, Ma HK. Discrepancy between laboratory determination and visual estimation of blood loss during normal delivery. Eur J Obstet Gynecol Reprod Biol. 1991 Jan 30;38(2):119-24. doi: 10.1016/0028-2243(91)90188-q.
PMID: 1995380
citation: Knight M, Callaghan WM, Berg C, Alexander S, Bouvier-Colle MH, Ford JB, Joseph KS, Lewis G, Liston RM, Roberts CL, Oats J, Walker J. Trends in postpartum hemorrhage in high resource countries: a review and recommendations from the International Postpartum Hemorrhage Collaborative Group. BMC Pregnancy Childbirth. 2009 Nov 27;9:55. doi: 10.1186/1471-2393-9-55.
PMID: 19943928
citation: Patel A, Goudar SS, Geller SE, Kodkany BS, Edlavitch SA, Wagh K, Patted SS, Naik VA, Moss N, Derman RJ. Drape estimation vs. visual assessment for estimating postpartum hemorrhage. Int J Gynaecol Obstet. 2006 Jun;93(3):220-4. doi: 10.1016/j.ijgo.2006.02.014. Epub 2006 Apr 12. Erratum In: Int J Gynaecol Obstet. 2006 Dec;95(3):312.
PMID: 16626718
citation: PRITCHARD JA. CHANGES IN THE BLOOD VOLUME DURING PREGNANCY AND DELIVERY. Anesthesiology. 1965 Jul-Aug;26:393-9. doi: 10.1097/00000542-196507000-00004. No abstract available.
PMID: 14313451
citation: Rath WH. Postpartum hemorrhage--update on problems of definitions and diagnosis. Acta Obstet Gynecol Scand. 2011 May;90(5):421-8. doi: 10.1111/j.1600-0412.2011.01107.x.
PMID: 21332452
citation: Royal College of Obstetrician and Gynaecologists. (2011). Postpartum hemorrhage: prevention and management. Retrieved May2, 2016 from http://www.cedepap.tv/GPC17.pdf
citation: Schorn MN. Measurement of blood loss: review of the literature. J Midwifery Womens Health. 2010 Jan-Feb;55(1):20-7. doi: 10.1016/j.jmwh.2009.02.014.
PMID: 20129226
citation: Stafford I, Dildy GA, Clark SL, Belfort MA. Visually estimated and calculated blood loss in vaginal and cesarean delivery. Am J Obstet Gynecol. 2008 Nov;199(5):519.e1-7. doi: 10.1016/j.ajog.2008.04.049. Epub 2008 Jul 17.
PMID: 18639209
citation: 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
citation: Toledo P, McCarthy RJ, Hewlett BJ, Fitzgerald PC, Wong CA. The accuracy of blood loss estimation after simulated vaginal delivery. Anesth Analg. 2007 Dec;105(6):1736-40, table of contents. doi: 10.1213/01.ane.0000286233.48111.d8.
PMID: 18042876
citation: 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
citation: Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011 Jan;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a. No abstract available.
PMID: 21173639
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
sharing ipd: No