Post-partum Hemorrhage (PPH) Clinical Trial
— ADOPTOfficial title:
Accurate Display of Postpartum Hemorrhage Using Triton (ADOPT) - A Retrospective Blinded Cohort Study
| NCT number | NCT02981758 |
| Other study ID # | Pro2016-0184 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2016 |
| Est. completion date | September 2019 |
| Verified date | February 2020 |
| Source | Hackensack Meridian Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | September 2019 |
| Est. primary completion date | July 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Hackensack Meridian Health |
United States,
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. — View 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. Review. — View Citation
Brant HA. Precise estimation of postpartum haemorrhage: difficulties and importance. Br Med J. 1967 Feb 18;1(5537):398-400. — View 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 J — View Citation
Centers for Disease Control and Prevention Mortality Data Run (November 17, 2015)
D'Alton ME, Main EK, Menard MK, Levy BS. The National Partnership for Maternal Safety. Obstet Gynecol. 2014 May;123(5):973-7. doi: 10.1097/AOG.0000000000000219. — View 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. — View 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. — View 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. — View 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 — View 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. Epub 2006 Apr 12. Erratum in: — View Citation
PRITCHARD JA. CHANGES IN THE BLOOD VOLUME DURING PREGNANCY AND DELIVERY. Anesthesiology. 1965 Jul-Aug;26:393-9. Review. — View 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. Review. — View Citation
Royal College of Obstetrician and Gynaecologists. (2011). Postpartum hemorrhage: prevention and management. Retrieved May2, 2016 from http://www.cedepap.tv/GPC17.pdf
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. Review. — View 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. — View 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
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. — View 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
Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011 Jan;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a. — View Citation
* Note: There are 20 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quantification of blood loss during vaginal deliveries | Retrospective Chart Review of blood loss during delivery | During labor | |
| Primary | Quantification of blood loss during vaginal deliveries | Retrospective Chart Review of blood loss during delivery | During delivery (intrapartum) | |
| Primary | Quantification of blood loss during vaginal deliveries | Retrospective Chart Review of blood loss during delivery | During immediate postpartum period. | |
| Secondary | 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. | Retrospective Chart Review of blood loss during delivery | During labor | |
| Secondary | Comparison of quantified blood loss (hemoglobin loss) using the The Triton™ | Retrospective Chart Review of blood loss during delivery | During delivery (intrapartum) | |
| Secondary | Comparison of quantified blood loss (hemoglobin loss) using the The Triton™ | Retrospective Chart Review of blood loss during delivery | During immediate postpartum period. |