CClinicalTrials.gg
Status unknownNCT03824743Updated Feb 4, 2019

Balanced Crystalloids in Postpartum Hemorrhage

An observational study in Postpartum Hemorrhage, sponsored by Fundación Santa Fe de Bogota. Status unknown at 1 site in Colombia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by Fundación Santa Fe de Bogota · Observational

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
Female
01

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.

Read the detailed description

Problem Statement Maternal mortality is a tragic event with great social, economic and legal impact. The incidence rate varies depending on the source, however, it covers 400 cases per 100,000 live births per year. The first cause of death in these patients is obstetric hemorrhage, which generates 150,000 deaths per year in the world. Not being outside of this situation, Bogotá presents a high number of women who present this complication, being the cause of death in 29% of cases in the years 2012 and 2013. Once this problem is identified, multiple strategies have sought to reduce maternal morbidity and mortality, one of the most influential being the "Millennium Development Goals", now called "Sustainable Development Goals". Associated with these, national and regional public policies are developed that seek to raise awareness about the importance of timely and early diagnosis, multidisciplinary and synchronous management among several health areas with the aim of preventing and treating obstetric hemorrhage to avoid fatal outcomes.

Within the prevention and management of obstetric bleeding, there are behaviors that have shown significant impact on outcomes, such as, for example, the administration of uterotonics in the active management of delivery, which reduce the risk of postpartum hemorrhage by up to 50% or the early administration of tranexamic acid, reducing mortality by 30%. However, despite these advances, a fundamental part of the initial handling of support is the volumetric resuscitation with crystalloids and in this field, although there is an indication to initiate replenishment of losses it is not clear what type of liquid to use and if any given their characteristics intrinsic can be superior to the other.

Justification In clinical practice, the goal of resuscitation is to return to cellular homeostasis. Normal saline has been used for volumetric resuscitation for more than 50 years. However, questions about its suitability have been raised given the association with negative outcomes given its composition and question whether modifications in these would bring better results. Multiple studies associated resuscitation with an unbalanced solution (normal saline) with hyperchloremic acidosis, acute kidney injury and morbidity in general, especially in the critically ill patient.

However, until now the evidence is not conclusive about whether this impact on the base acid state, hydroelectrolytic imbalance, and potential kidney injury is less with "balanced" solutions and generate better clinical results in all scenarios, surgical patients, patients and particularly in hypovolemic shock due to obstetric hemorrhage.

Research question Are there differences in the volume of fluids and blood products to be used in the outcomes of patients with obstetric hemorrhage with the use of balanced crystalloids (Lactate Ringer or Plasma-Lyte) at the Hospital Universitario Santa Fe de Bogotá during the years 2018 - 2019?

02

Conditions studied

  • Postpartum Hemorrhage
03

In context

Postpartum Hemorrhage

445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.

This study's planned enrollment of 40 is below the median of 150 across 91 observational studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

Fundación Santa Fe de Bogota is the lead sponsor of 26 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Universe population: Patients with obstetric hemorrhage in the Hospital Universitario Fundación Santa Fe de Bogotá.

Study population: Patients with obstetric hemorrhage at the Hospital Universitario Fundación Santa Fe de Bogotá that meet the inclusion criteria.

Inclusion criteria

  • Patient with a diagnosis of obstetric hemorrhage (> 1000 mL). Over 18 years.

Exclusion criteria

Exclusion Criteria:

  • Patients with incomplete clinical history.
  • Patients with active infections.
  • Patients with a history of blood dyscrasias.
  • Patients with known kidney disease.
  • Patient with previous alteration of the acid-base status.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Lactate Ringer

    Patients managed with Ringer Lactate

    Drug: Lactate Ringer

  • Plasma-Lyte

    Patients managed with Plasma-Lyte

    Drug: Plasma-lyte

Interventions

  • DrugLactate Ringer

    Patients managed with Lactate Ringer and obstetric hemorrhage

    Also known as: Cristalloids

  • DrugPlasma-lyte

    Patients managed with Plasma-Lyte and obstetric hemorrhage

    Also known as: Balanced cristalloids

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What researchers measure

Primary outcomes

  1. Differences in the use of fluids and blood products

    Differences in the use of fluids and blood products with the use of balanced crystalloids in obstetric hemorrhage

    Time frame: 2018 - 2019

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Study locations

1 of 1 sites recruiting
  • Hospital Universitario Fundación Santa Fe de Bogotá
    Bogotá, 110111, Colombia
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03824743
Lead sponsor
Fundación Santa Fe de Bogota
Responsible party
Leopoldo Ferrer (Principal investigator, Fundación Santa Fe de Bogota) — Principal investigator
First posted
Jan 31, 2019
Start date
Jan 25, 2019
Primary completion
May 30, 2020 (estimated)
Completion
Jul 30, 2020 (estimated)
Last update
Feb 4, 2019

Study contacts

Leopoldo E Ferrer, M.D.
Contact
lfanesthesia@gmail.com
(57) 6030303 ext. 5016
Guillermo A Madrid, M.D.
Contact
gamanesthesia@gmail.com
(57) 6030303 ext. 5016
Leopoldo E Ferrer, M.D.
principal investigator · Hospital Universitario Fundación Santa Fe de Bogotá

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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