The Association Between Shock Index and Severity of Postpartum Blood Loss

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Other: Exposure to vaginal delivery

• Registration Number: NCT03135158
• Lead Sponsor: Gynuity Health Projects

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-18
• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-01
• Primary Completion: 2017-11-30
• Study Completion: 2017-12-05
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 298

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women in labor	Exposure to vaginal delivery	All participants who have a vaginal delivery

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fundación Valle del Lili; 🇨🇴 Cali, Colombia