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The Association Between Shock Index and Severity of Postpartum Blood Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03135158
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Fundacion Clinica Valle del Lili
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Postpartum Hemorrhage Other: Exposure to vaginal delivery

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Study Type : Observational
Actual Enrollment : 298 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Association Between Shock Index and Severity of Postpartum Blood Loss: An Observational Study
Actual Study Start Date : April 18, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : December 5, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All women presenting for vaginal delivery will be invited to participate
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135158


Locations
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Colombia
Fundación Valle del Lili
Cali, Colombia
Sponsors and Collaborators
Gynuity Health Projects
Fundacion Clinica Valle del Lili
Investigators
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Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Principal Investigator: Jill Durocher Gynuity Health Projects
Principal Investigator: Ilana Dzuba, MPH Gynuity Health Projects

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT03135158     History of Changes
Other Study ID Numbers: 3009
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage