Blood Loss Measurement During Cesarean Delivery

NCT02667600 | Completed

• 1 other identifier: 35648
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the ability of the Triton Device to measure blood loss among women undergoing elective and non-elective cesarean delivery. This patient population often experiences significant blood loss during surgery, and measurements of surgical blood loss are often inaccurate.

Conditions

Pregnancy

Keywords

Cesarean; Blood Loss; Triton

Outcome Measures

Primary Outcomes (1)

• Difference in blood loss measurements

  Compare blood loss estimates between the triton device, visual estimation of blood loss, and cumulative measurements of blood loss during a cesarean delivery

  Day Of Surgery

Secondary Outcomes (1)

• Triton Blood Loss Prediction of Post Partum Hemoglobin

  24-48 hours post surgery

Study Arms (1)

Cesarean Section Group

Patients undergoing cesarean section

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy female patients undergoing uncomplicated Cesarean delivery

You may qualify if:

• American Society of Anesthesiologists physical status class I-III
• undergoing Cesarean delivery under neuraxial anesthesia
• age between 18 and 50
• gestational age greater than or equal to 37 completed weeks
• all ethnicities

You may not qualify if:

• contraindication for epidural or spinal analgesia (bleeding diathesis, neuropathy, severe scoliosis, local anesthetic allergy)
• inability to adequately understand the consent form

Sponsors & Collaborators

• Alex James Butwick: lead

Study Sites (1)

Lucille Packard Children's Hospital

Palo Alto, California, 94305, United States

Location

Related Publications (4)

• 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 BACKGROUND

• Konig G, Holmes AA, Garcia R, Mendoza JM, Javidroozi M, Satish S, Waters JH. In vitro evaluation of a novel system for monitoring surgical hemoglobin loss. Anesth Analg. 2014 Sep;119(3):595-600. doi: 10.1213/ANE.0000000000000198.

  PMID: 24806138 BACKGROUND

• Holmes AA, Konig G, Ting V, Philip B, Puzio T, Satish S, Waters JH. Clinical evaluation of a novel system for monitoring surgical hemoglobin loss. Anesth Analg. 2014 Sep;119(3):588-594. doi: 10.1213/ANE.0000000000000181.

  PMID: 24797122 BACKGROUND

• Fedoruk K, Seligman KM, Carvalho B, Butwick AJ. Assessing the Association Between Blood Loss and Postoperative Hemoglobin After Cesarean Delivery: A Prospective Study of 4 Blood Loss Measurement Modalities. Anesth Analg. 2019 May;128(5):926-932. doi: 10.1213/ANE.0000000000003449.

  PMID: 29847380 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander J Butwick, FRCA

  Stanford University

  PRINCIPAL INVESTIGATOR

• Brendan Carvalho, MBBCh, FRCA

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, Perioperative and Pain Medicine (OB)

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: January 29, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 12, 2017
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

US (1)