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Postpartum HemorrhageNCT03824743

Balanced Crystalloids in Postpartum Hemorrhage

An observational study of Postpartum Hemorrhage, run by Fundación Santa Fe de Bogota at 1 site in Colombia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Postpartum Hemorrhage
What is being tested?
Lactate Ringer and Plasma-lyte
How many people
40 participants
Where
1 siteColombia
Study dates
25 Jan 2019to 30 Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Leopoldo E Ferrer, M.D. contact

(57) 6030303 ext. 5016

lfanesthesia@gmail.com

Guillermo A Madrid, M.D. contact

(57) 6030303 ext. 5016

gamanesthesia@gmail.com

Colombia1 site, 1 recruiting
  • Hospital Universitario Fundación Santa Fe de Bogotá

    Bogotá, 110111

    Leopoldo E Ferrer, M.D., 6030303 ext. 5016, lfanesthesia@gmail.com

    Recruiting

Other trials in Colombia

About this study

Official title: Impact of Balanced Crystalloids in Obstetric Hemorrhage: A Prospective Cohort Study

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.

Read more

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?

Being tested
Lactate Ringer, Plasma-lyte
Medical subject headings
Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactate RingerDrug

    Also called Cristalloids

    Patients managed with Lactate Ringer and obstetric hemorrhage

  • Plasma-lyteDrug

    Also called Balanced cristalloids

    Patients managed with Plasma-Lyte and obstetric hemorrhage

Study groups in NCT03824743
Study groupRoleWhat they receive
Lactate RingerPatients managed with Ringer Lactate
Receives: Drug: Lactate Ringer
Plasma-LytePatients managed with Plasma-Lyte
Receives: Drug: Plasma-lyte

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2018 - 2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2019
  2. Study start25 Jan 2019
  3. Primary completion30 May 2020 (estimated)
  4. Study completion30 Jul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03824743
Sponsor's protocol ID
CCEI-9813-2018
Status last verified
Jan 2019
First submitted
25 Jan 2019
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Postpartum Hemorrhage, run by Fundación Santa Fe de Bogota at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Leopoldo E Ferrer, M.D. ((57) 6030303 ext. 5016, lfanesthesia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in the use of fluids and blood products (time frame: 2018 - 2019). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.

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