NCT02981758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

November 18, 2016

Last Update Submit

February 10, 2020

Conditions

Post-partum Hemorrhage (PPH)

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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.

    During labor

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

    During delivery (intrapartum)

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

    During immediate postpartum period.

Study Arms (2)

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.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women who delivered (vaginally) at HackensackUMC between 2010 and 2015 who had blood loss during the delivery.

You may qualify if:

  • 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).

You may not qualify if:

  • Women who received transfusions unrelated directly to pregnancy (e.g. renal disease, anemia of pregnancy, genetic or viral conditions causing anemia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (20)

  • 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: 20508942RESULT

  • 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: 16319245RESULT

  • 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: 5297397RESULT

  • 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: 22844432RESULT

  • Centers for Disease Control and Prevention Mortality Data Run (November 17, 2015)

    RESULT

  • 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: 24785848RESULT

  • 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: 21698554RESULT

  • 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: 15339775RESULT

  • 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: 1995380RESULT

  • 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: 19943928RESULT

  • 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.

    PMID: 16626718RESULT

  • 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: 14313451RESULT

  • 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: 21332452RESULT

  • Royal College of Obstetrician and Gynaecologists. (2011). Postpartum hemorrhage: prevention and management. Retrieved May2, 2016 from http://www.cedepap.tv/GPC17.pdf

    RESULT

  • 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: 20129226RESULT

  • 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: 18639209RESULT

  • Joint Commission on Accreditation of Healthcare Organizations, USA. Preventing maternal death. Sentinel Event Alert. 2010 Jan 26;(44):1-4. No abstract available.

    PMID: 20183946RESULT

  • 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: 18042876RESULT

  • 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

    RESULT

  • 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: 21173639RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew Rubenstein, M.D.

    Hackensack Meridian Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2016

First Posted

December 5, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2018

Study Completion

September 1, 2019

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)