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Completed

NCT Number: NCT03135158

The Association Between Shock Index and Severity of Postpartum Blood Loss

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

Primary location

Fundación Valle del Lili

Cali, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure to vaginal delivery

Other

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

Primary outcomes

  1. 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

  1. Percentage of women with blood loss ≥ 500 ml and ≥ 1000 ml

    Time frame: 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

  2. Median blood loss in the postpartum and interquartile range

    Time frame: Up to two hours postpartum

    Blood loss at 30 and 60 minutes postpartum, at PPH diagnosis (if applicable), and when active bleeding stops

  3. Percentage of women who received treatment to control bleeding

    Time frame: Up to two hours postpartum

  4. Average change in Hb measured before and after delivery

    Time frame: Pre-delivery and at least 24 hours postpartum

    Among women receiving treatment to control postpartum hemorrhage

  5. Percentage of women with complications

    Time frame: Through study completion, an average of 24-48 hours postpartum

    Among women receiving treatment to control postpartum hemorrhage

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Fundacion Clinica Valle del Lili

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 1, 2017
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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