The Association Between Shock Index and Severity of Postpartum Blood Loss

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135158
• Other study ID #: 3009
• Status: Completed
• Start date: April 18, 2017
• Est. completion date: December 5, 2017

Study information

• Verified date: April 2018
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: December 5, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Colombia	Fundación Valle del Lili	Cali

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Fundacion Clinica Valle del Lili

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Percentage of women who received treatment to control bleeding		Up to two hours postpartum
Secondary	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
Secondary	Percentage of women with complications	Among women receiving treatment to control postpartum hemorrhage	Through study completion, an average of 24-48 hours postpartum