The Association Between Shock Index and Severity of Postpartum Blood Loss

NCT03135158 | Completed DMC

• 1 other identifier: 3009
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of women with blood loss ≥ 500 ml and ≥ 1000 ml

  Up to two hours postpartum

• Median blood loss in the postpartum and interquartile range

  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

Study Arms (1)

Women in labor

All participants who have a vaginal delivery

Other: Exposure to vaginal delivery

Interventions

Exposure to vaginal delivery OTHER

Women who have vaginal births are observed for a minimum of 1 hour postpartum

Women in labor

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women presenting for vaginal delivery will be invited to participate

You may qualify if:

• Receive care for vaginal delivery

You may not qualify if:

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

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Fundacion Clinica Valle del Lili: collaborator

Study Sites (1)

Fundación Valle del Lili

Cali, Colombia

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Jill Durocher

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Ilana Dzuba, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 1, 2017
• Study Start: April 18, 2017
• Primary Completion: November 30, 2017
• Study Completion: December 5, 2017
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

CO (1)