The Association Between Shock Index and Severity of Postpartum Blood Loss

Overview

The present study aims to determine the relationship between postpartum changes in the shock index and the severity of blood loss and other PPH results. Blood loss, heart rate and blood pressure will be systematically measured in the postpartum period in all participating women to explore new clinical indicators to identify those requiring clinical intervention for excessive bleeding.

Full Title of Study: “The Association Between Shock Index and Severity of Postpartum Blood Loss: An Observational Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 30, 2017

Interventions

  • Other: Exposure to vaginal delivery
    • Women who have vaginal births are observed for a minimum of 1 hour postpartum

Arms, Groups and Cohorts

  • Women in labor
    • All participants who have a vaginal delivery

Clinical Trial Outcome Measures

Primary Measures

  • Correlation between blood loss and shock index
    • Time Frame: Within 1 hour postpartum
    • Correlate shock index, heart rate, and blood pressure measurements with blood loss levels at 15, 30, 45 & 60 minutes

Secondary Measures

  • Percentage of women with blood loss ≥ 500 ml and ≥ 1000 ml
    • Time Frame: Up to two hours postpartum
    • Proportions with ≥ 500 ml and ≥ 1000 ml blood loss at 30 and 60 minutes postpartum, at PPH diagnosis (if applicable), and when active bleeding stops
  • Median blood loss in the postpartum and interquartile range
    • Time Frame: Up to two hours postpartum
    • Blood loss at 30 and 60 minutes postpartum, at PPH diagnosis (if applicable), and when active bleeding stops
  • Percentage of women who received treatment to control bleeding
    • Time Frame: Up to two hours postpartum
  • Average change in Hb measured before and after delivery
    • Time Frame: Pre-delivery and at least 24 hours postpartum
    • Among women receiving treatment to control postpartum hemorrhage
  • Percentage of women with complications
    • Time Frame: Through study completion, an average of 24-48 hours postpartum
    • Among women receiving treatment to control postpartum hemorrhage

Participating in This Clinical Trial

Inclusion Criteria

  • Receive care for vaginal delivery Exclusion Criteria:

  • Scheduled or transferred for cesarean section – Cannot give informed consent – Are not willing and/or cannot answer the questionnaire on their background

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Gynuity Health Projects
  • Collaborator
    • Fundacion Clinica Valle del Lili
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Beverly Winikoff, MD, MPH, Principal Investigator, Gynuity Health Projects
    • Jill Durocher, Principal Investigator, Gynuity Health Projects
    • Ilana Dzuba, MPH, Principal Investigator, Gynuity Health Projects

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