Hypertension in PregnancyNCT06403722
Perinatal Outcomes in Patients With Elevated sFlt-1/PlGF Ratio
An observational study of Hypertension in Pregnancy, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
Retrospective cohort study that evaluated 190 subjects admitted with diagnosis of hypertensive disorder of pregnancy, between 24 and 36 6/7 weeks, with an sFlt-1/PlGF index greater than or equal to 110. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hypertension in Pregnancy
- How many people
- 190 participants
- Where
- 1 sitePanama
- Study dates
- 15 Nov 2023to 30 Jan 2024
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects admitted with suspicion of preeclampsia, between 24 and 36 6/7 weeks with result of sFlt-1/PlGF before delivery.
Who may be able to join
- Diagnosis of hypertensive disorder of pregnancy
- Gestational age between 24 - 36 6/7
- sFlt-1/PlGF > 110
Who cannot join
- Gestational age below 23 6/7 weeks and above 37 weeks at the moment of admission.
- Absence of sFLt-1/PlGF ratio result.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perinatal Outcomes in Patients With Suspicion of Preeclampsia and Elevated sFlt-1/PlGF Before Term: A Retrospective Cohort Study
Retrospective cohort study that evaluated 190 subjects admitted with diagnosis of hypertensive disorder of pregnancy, between 24 and 36 6/7 weeks, with an sFlt-1/PlGF index greater than or equal to 110. Data were collected on their clinical course prior to termination of pregnancy, using the last reported sFlt-1/PlGF ratio value to classify the population into four cohorts: values between 110-205, between 206 and 654, between 655 and 999 and greater than 1000.
- Conditions
- Hypertension in Pregnancy
- Being tested
- Standard of care
- Keywords
- Hypertension, pregnancy induced, Angiogenic factors
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careDiagnostic test
No intervention. Clinical evolution was recorded, looking for perinatal complications.
| Study group | Role | What they receive |
|---|---|---|
| sFlt-1/PlGF: 110-205 | Subjects with suspicion of preeclampsia, with gestational age between 24 - 36 6/7 weeks and sFlt-1/PlGF between 110-205. Receives: Diagnostic Test: Standard of care | |
| sFlt-1/PlGF: 206-654 | Subjects with suspicion of preeclampsia, with gestational age between 24 - 36 6/7 weeks and sFlt-1/PlGF between 206-654. Receives: Diagnostic Test: Standard of care | |
| sFlt-1/PlGF: 655-999 | Subjects with suspicion of preeclampsia, with gestational age between 24 - 36 6/7 weeks and sFlt-1/PlGF between 655-999. Receives: Diagnostic Test: Standard of care | |
| sFlt-1/PlGF > 1000 | Subjects with suspicion of preeclampsia, with gestational age between 24 - 36 6/7 weeks and sFlt-1/PlGF above 1000. Receives: Diagnostic Test: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney injury
Creatinine level > 1.1 Doubling of creatinine levels when others causes had been excluded
Measured: From the moment of admission up until discharge after delivery, average 5 to 10 days
Hepatic enzyme abnormalities
Increase of liver enzyme to > twice the upper limit of normal
Measured: From the moment of admission up until discharge after delivery, average 5 to 10 days
HELLP Syndrome
Elevated liver enzymes Thrombocytopenia Hemolysis
Measured: From the moment of admission up until discharge after delivery, average 5 to 10 days
Growth restricted fetus
Fetal weight below 10th percentile and abnormal doppler Fetal weight below 3th percentile
Measured: From the moment of admission up until delivery, average 5 to 10 days
Stillbirth
Intrauterine fetal demise
Measured: From the moment of admission up until discharge after delivery, average 5 to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start15 Nov 2023
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in PregnancyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 190 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403722
- Sponsor's protocol ID
- 2023-631
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 8 May 2024
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Outcomes in Patients With Suspicion of Preeclampsia and Elevated sFlt-1/PlGF Before Term: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06403722
- Acronym / sponsor ID
- 2023-631
- Conditions
- Hypertension in Pregnancy
- Keywords
- Hypertension, pregnancy induced, Angiogenic factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 8 May 2024 (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.
Retrospective cohort study that evaluated 190 subjects admitted with diagnosis of hypertensive disorder of pregnancy, between 24 and 36 6/7 weeks, with an sFlt-1/PlGF index greater than or equal to 110. Data were collected on their clinical course prior to termination of pregnancy, using the last reported sFlt-1/PlGF ratio value to classify the population into four cohorts: values between 110-205, between 206 and 654, between 655 and 999 and greater than 1000.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sFlt-1/PlGF: 110-205 | – | Diagnostic Test: Standard of careSubjects with suspicion of preeclampsia, with gestational age between 24 - 36 6/7 weeks and sFlt-1/PlGF between 110-205. |
| sFlt-1/PlGF: 206-654 | – | Diagnostic Test: Standard of careSubjects with suspicion of preeclampsia, with gestational age between 24 - 36 6/7 weeks and sFlt-1/PlGF between 206-654. |
| sFlt-1/PlGF: 655-999 | – | Diagnostic Test: Standard of careSubjects with suspicion of preeclampsia, with gestational age between 24 - 36 6/7 weeks and sFlt-1/PlGF between 655-999. |
| sFlt-1/PlGF > 1000 | – | Diagnostic Test: Standard of careSubjects with suspicion of preeclampsia, with gestational age between 24 - 36 6/7 weeks and sFlt-1/PlGF above 1000. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects admitted with suspicion of preeclampsia, between 24 and 36 6/7 weeks with result of sFlt-1/PlGF before delivery.
Key inclusion criteria (3 listed)
- Diagnosis of hypertensive disorder of pregnancy
- Gestational age between 24 - 36 6/7
- sFlt-1/PlGF > 110
Key exclusion criteria (2 listed)
- Gestational age below 23 6/7 weeks and above 37 weeks at the moment of admission.
- Absence of sFLt-1/PlGF ratio result.
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 |
|---|---|---|
| Standard of careNo intervention. Clinical evolution was recorded, looking for perinatal complications. | Diagnostic test | sFlt-1/PlGF > 1000, sFlt-1/PlGF: 110-205, sFlt-1/PlGF: 206-654, sFlt-1/PlGF: 655-999 |
Primary outcome
Kidney injury
Time frame: From the moment of admission up until discharge after delivery, average 5 to 10 days
Creatinine level > 1.1 Doubling of creatinine levels when others causes had been excluded
Hepatic enzyme abnormalities
Time frame: From the moment of admission up until discharge after delivery, average 5 to 10 days
Increase of liver enzyme to > twice the upper limit of normal
HELLP Syndrome
Time frame: From the moment of admission up until discharge after delivery, average 5 to 10 days
Elevated liver enzymes Thrombocytopenia Hemolysis
Growth restricted fetus
Time frame: From the moment of admission up until delivery, average 5 to 10 days
Fetal weight below 10th percentile and abnormal doppler Fetal weight below 3th percentile
Stillbirth
Time frame: From the moment of admission up until discharge after delivery, average 5 to 10 days
Intrauterine fetal demise
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 8 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension in Pregnancy, 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 2 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 8 May 2024. 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?
Kidney injury (time frame: From the moment of admission up until discharge after delivery, average 5 to 10 days). The study lists 5 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 8 May 2024.