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Balanced Crystalloids in Postpartum Hemorrhage

NCT03824743 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2019-02-04

No results posted yet for this study

Summary

Introduction:

Obstetric hemorrhage is the most feared complication that can occur during childbirth and continues to be the leading cause of death in pregnant women worldwide, about 7 women die every hour in the world. This is defined as an accumulated loss of blood of more than 1000 mL with signs and symptoms of hypovolemia within 24 hours of the birth process. The main objective of resuscitation in these patients is precisely to reduce the deleterious effects that are generated from the depletion of volume and the altered capacity of oxygen transport. The current debate focuses on the safety and efficacy of each particular liquid during resuscitation and on improving long-term patient outcomes. At present, there is no conclusive evidence on the impact at the level of acid-base status, hydroelectrolytic balance and potential kidney injury with respect to the use of balanced solutions such as Plasma-Lyte or Ringer's Lactate.

Objective:

To determine the differences in the volume of liquids and blood products required with the use of balanced crystalloids (Ringer's Lactate or Plasma-Lyte) in patients with obstetric hemorrhage in the Hospital Universitario Fundación Santa Fe de Bogotá during 2018 - 2019.

Design, Materials, and methods:

Historical cohort analytical study. All patients over 18 years of age who present an obstetric hemorrhage defined as bleeding\> 1000 mL or less associated with signs or symptoms of hemodynamic instability will be included. The most important exclusion criterion is the presence of active infection at the time of the event. Patients will be divided into two groups, those who underwent hydroelectrolytic resuscitation with Plasma-Lyte and Ringer Lactate.

Results and conclusions With this study, we intend to describe the differences in the base acid status measured by arterial gases in patients with obstetric hemorrhage. The aim is to find a relationship between the different groups with clinical outcomes, such as days of ICU stay and hospitalization, blood transfusion requirement, electrolyte disorders, acute kidney injury and survival.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Lactate Ringer

Patients managed with Lactate Ringer and obstetric hemorrhage

DRUG

Plasma-lyte

Patients managed with Plasma-Lyte and obstetric hemorrhage

Sponsors & Collaborators

  • Fundación Santa Fe de Bogota

    lead OTHER

Principal Investigators

  • Leopoldo E Ferrer, M.D. · Hospital Universitario Fundación Santa Fe de Bogotá

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-25
Primary Completion
2020-05-30
Completion
2020-07-30

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03824743 on ClinicalTrials.gov