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Clinical Trials/NCT03135158
NCT03135158
Completed
Not Applicable

The Association Between Shock Index and Severity of Postpartum Blood Loss: An Observational Study

Gynuity Health Projects1 site in 1 country298 target enrollmentApril 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Hemorrhage
Sponsor
Gynuity Health Projects
Enrollment
298
Locations
1
Primary Endpoint
Correlation between blood loss and shock index
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 18, 2017
End Date
December 5, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Gynuity Health Projects
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Percentage of women with blood loss ≥ 500 ml and ≥ 1000 ml(Up to two hours postpartum)
  • Percentage of women who received treatment to control bleeding(Up to two hours postpartum)
  • Average change in Hb measured before and after delivery(Pre-delivery and at least 24 hours postpartum)
  • Percentage of women with complications(Through study completion, an average of 24-48 hours postpartum)
  • Median blood loss in the postpartum and interquartile range(Up to two hours postpartum)

Study Sites (1)

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