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

NCT07265336 | Recruiting

• 1 other identifier: 4558
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia; Severe Preeclampsia

Keywords

Excess base; Severe preeclampsia; Arterial blood gases

Outcome Measures

Primary Outcomes (2)

• Value of excess base

  Total measure of excess base measured by gasometry in an arterial blood sample

  Immediately before delivery

• Hypertensive crisis

  Elevation of the blood pressure above 160 (systolic) and 110 (diastolic).

  From admission to day three (3) after delivery

Secondary Outcomes (2)

• Lactate

  Immediately before delivery

• Bicarbonate

  Immediately before delivery

Study Arms (2)

Severe preeclampsia

EXPERIMENTAL

Pregnant subjects with severe preeclampsia

Diagnostic Test: Arterial Blood gases

Normotensive

EXPERIMENTAL

Pregnant subjects with normal blood pressure

Diagnostic Test: Arterial Blood gases

Interventions

Arterial Blood gases DIAGNOSTIC_TEST

Determination of Excess Base in arterial blood gases before delivery / termination of pregnancy

Normotensive; Severe preeclampsia

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Thomas Hospital, Panama: lead

Study Sites (1)

Saint Thomas Hospital

Panama City, Provincia de Panamá, Panama

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Osvaldo Reyes, MD

  Saint Thomas Hospital, Panama

  STUDY CHAIR

Central Study Contacts

Francisco Jordan, MD

CONTACT

+507 6983-0029; fcojordan19@gmail.com

Adriana Martinz, MD

CONTACT

amartinzmd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Department

Model Details: Both groups will have a blood sample taken for arterial blood gases. This test is not always indicated in severe preeclampsia and very rarely in normal patients. This is he reason we consider the study interventional.

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: December 4, 2025
• Study Start: August 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)