Excess Base Comparison Between Pregnant Subjects With Severe Preeclampsia vs. Normotensive Pregnant Women

December 2, 2025 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Comparison of Base Excess in Arterial Blood Gases Between Patients With Severe Preeclampsia and Normotensive Pregnant Patients

The study's primary goal is to compare the base excess (BE) values-an indicator of metabolic changes-in two groups of patients at Santo Tomás Hospital: those with severe preeclampsia and healthy, pregnant individuals. Researchers will measure these values using an arterial blood gas test before delivery or surgery.

This is a prospective cohort study. The researchers will analyze various blood gas parameters, including pH, lactate, and BE, and then correlate the BE values with clinical variables and negative maternal outcomes.

The expected outcome is that a abnormal BE values will be linked to a greater severity of preeclampsia. If this association is confirmed, BE could serve as an additional marker for predicting the severity of the condition and may lay the groundwork for future research on diagnostic and therapeutic standards based on blood gas analysis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Panama
    • Provincia de Panamá
      • Panama City, Provincia de Panamá, Panama
        • Recruiting
        • Saint Thomas Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Gestational age: 24-40 weeks
  • Cases: Diagnosis of severe preeclampsia
  • Control: Normal blood pressure

Exclusion Criteria:

  • Metabolic conditions that could hinder the results (diabetic ketoacidosis, sepsis, renal failure).
  • Clinical conditions that could hinder the results (diarrhea, vomit)
  • Recent use of bicarbonate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Severe preeclampsia
Pregnant subjects with severe preeclampsia
Diagnostic test: Arterial Blood gases
Determination of Excess Base in arterial blood gases before delivery / termination of pregnancy
Experimental: Normotensive
Pregnant subjects with normal blood pressure
Diagnostic test: Arterial Blood gases
Determination of Excess Base in arterial blood gases before delivery / termination of pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Value of excess base
Time Frame: Immediately before delivery
Total measure of excess base measured by gasometry in an arterial blood sample
Immediately before delivery
Hypertensive crisis
Time Frame: From admission to day three (3) after delivery
Elevation of the blood pressure above 160 (systolic) and 110 (diastolic).
From admission to day three (3) after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lactate
Time Frame: Immediately before delivery
Concentration of lactate measured by gasometry in a sample of arterial blood.
Immediately before delivery
Bicarbonate
Time Frame: Immediately before delivery
Concentration of bicarbonate measured by gasometry in arterial blood gases
Immediately before delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Investigators

  • Study Chair: Osvaldo Reyes, MD, Saint Thomas Hospital, Panama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

August 24, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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