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The Association Between Shock Index and Severity of Postpartum Blood Loss

NCT ID: NCT03135158

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

298 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-18

Study Completion Date

2017-12-05

Brief Summary

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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

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Conditions

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Postpartum Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women in labor

All participants who have a vaginal delivery

Exposure to vaginal delivery

Intervention Type OTHER

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

Interventions

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Exposure to vaginal delivery

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundacion Clinica Valle del Lili

OTHER

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beverly Winikoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Jill Durocher

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Ilana Dzuba, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

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Fundación Valle del Lili

Cali, , Colombia

Site Status

Countries

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Colombia

Other Identifiers

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3009

Identifier Type: -

Identifier Source: org_study_id