PreeclampsiaNCT07265336
Excess Base Comparison Between Pregnant Subjects With Severe Preeclampsia vs. Normotensive Pregnant Women
A study testing Arterial Blood gases in people with Preeclampsia and Severe Preeclampsia, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Severe Preeclampsia
- What is being tested?
- Arterial Blood gases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePanama
- Study dates
- 15 Aug 2025to 31 Mar 2026
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gestational age: 24-40 weeks
- Cases: Diagnosis of severe preeclampsia
- Control: Normal blood pressure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Preeclampsia, Severe Preeclampsia
- Being tested
- Arterial Blood gases
- Keywords
- Excess base, Severe preeclampsia, Arterial blood gases
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Blood gasesDiagnostic test
Determination of Excess Base in arterial blood gases before delivery / termination of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Severe preeclampsia | Experimental | Pregnant subjects with severe preeclampsia Receives: Diagnostic Test: Arterial Blood gases |
| Normotensive | Experimental | Pregnant subjects with normal blood pressure Receives: Diagnostic Test: Arterial Blood gases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of excess base
Total measure of excess base measured by gasometry in an arterial blood sample
Measured: Immediately before delivery
Hypertensive crisis
Elevation of the blood pressure above 160 (systolic) and 110 (diastolic).
Measured: From admission to day three (3) after delivery
Secondary outcomes (2)
Lactate
Concentration of lactate measured by gasometry in a sample of arterial blood.
Measured: Immediately before delivery
Bicarbonate
Concentration of bicarbonate measured by gasometry in arterial blood gases
Measured: Immediately before delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start15 Aug 2025
- Primary completion20 Feb 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Osvaldo Reyes, MD, Study chair, Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265336
- Sponsor's protocol ID
- 4558
- Status last verified
- Jul 2026
- First submitted
- 24 Aug 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Base Excess in Arterial Blood Gases Between Patients With Severe Preeclampsia and Normotensive Pregnant Patients
- ClinicalTrials.gov ID
- NCT07265336
- Acronym / sponsor ID
- 4558
- Conditions
- Preeclampsia, Severe Preeclampsia
- Keywords
- Excess base, Severe preeclampsia, Arterial blood gases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Severe preeclampsia | Experimental | Diagnostic Test: Arterial Blood gasesPregnant subjects with severe preeclampsia |
| Normotensive | Experimental | Diagnostic Test: Arterial Blood gasesPregnant subjects with normal blood pressure |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age: 24-40 weeks
- Cases: Diagnosis of severe preeclampsia
- Control: Normal blood pressure
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial Blood gasesDetermination of Excess Base in arterial blood gases before delivery / termination of pregnancy | Diagnostic test | Normotensive, Severe preeclampsia |
Primary outcome
Value of excess base
Time frame: Immediately before delivery
Total measure of excess base measured by gasometry in an arterial blood sample
Hypertensive crisis
Time frame: From admission to day three (3) after delivery
Elevation of the blood pressure above 160 (systolic) and 110 (diastolic).
2 secondary outcomes
Lactate
Time frame: Immediately before delivery
Bicarbonate
Time frame: Immediately before delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
RecruitingPhase 4
AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Hypertensive Disorders of Pregnancy, Preeclampsia
RecruitingPhase 2
Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
Preeclampsia
Enrolling by invitation
MumCare: Mum's Cardiovascular Health for Life
Hypertensive Disorder of Pregnancy, Preeclampsia
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osvaldo Reyes, MD study chair
Saint Thomas Hospital, Panama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial Blood gases in people with Preeclampsia and Severe Preeclampsia, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 16 Jul 2026. 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 Panama. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of excess base (time frame: Immediately before delivery). The study lists 2 primary outcomes in all. 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 16 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.