The Association Between Shock Index and Severity of Postpartum Blood Loss

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Other: Exposure to vaginal delivery

• Study Type: Observational
• Enrollment (Actual): 298

Contacts and Locations

Study Locations

• Colombia
  • Cali, Colombia
    • Fundacion Valle del Lili

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All women presenting for vaginal delivery will be invited to participate

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women in labor; All participants who have a vaginal delivery	Other: Exposure to vaginal delivery; Women who have vaginal births are observed for a minimum of 1 hour postpartum

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Fundacion Clinica Valle del Lili
• Investigators: Principal Investigator: Jill Durocher, Gynuity Health Projects; Principal Investigator: Ilana Dzuba, MPH, Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): December 5, 2017

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: 3009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No