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

NCT ID: NCT07265336

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Preeclampsia Severe Preeclampsia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Severe preeclampsia

Pregnant subjects with severe preeclampsia

Group Type EXPERIMENTAL

Arterial Blood gases

Intervention Type DIAGNOSTIC_TEST

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

Normotensive

Pregnant subjects with normal blood pressure

Group Type EXPERIMENTAL

Arterial Blood gases

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Arterial Blood gases

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Head of Research Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osvaldo Reyes, MD

Role: STUDY_CHAIR

Saint Thomas Hospital, Panama

Locations

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Saint Thomas Hospital

Panama City, Provincia de Panamá, Panama

Site Status RECRUITING

Countries

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Panama

Central Contacts

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Francisco Jordan, MD

Role: CONTACT

+507 6983-0029

Adriana Martinz, MD

Role: CONTACT

Facility Contacts

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Osvaldo A Reyes, MD

Role: primary

o11(507)65655041

Other Identifiers

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4558

Identifier Type: -

Identifier Source: org_study_id

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