Perinatal Outcomes in Patients With Elevated sFlt-1/PlGF Ratio

May 2, 2024 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Contacts and Locations

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

Study Locations

  • Panama
      • Panama, Panama
        • Saint Thomas H

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects admitted with suspicion of preeclampsia, between 24 and 36 6/7 weeks with result of sFlt-1/PlGF before delivery.

Description

Inclusion Criteria:

  • Diagnosis of hypertensive disorder of pregnancy
  • Gestational age between 24 - 36 6/7
  • sFlt-1/PlGF > 110

Exclusion Criteria:

  • Gestational age below 23 6/7 weeks and above 37 weeks at the moment of admission.
  • Absence of sFLt-1/PlGF ratio result.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: Standard of care
No intervention. Clinical evolution was recorded, looking for perinatal complications.
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.
Diagnostic test: Standard of care
No intervention. Clinical evolution was recorded, looking for perinatal complications.
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.
Diagnostic test: Standard of care
No intervention. Clinical evolution was recorded, looking for perinatal complications.
sFlt-1/PlGF > 1000
Subjects with suspicion of preeclampsia, with gestational age between 24 - 36 6/7 weeks and sFlt-1/PlGF above 1000.
Diagnostic test: Standard of care
No intervention. Clinical evolution was recorded, looking for perinatal complications.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From the moment of admission up until discharge after delivery, average 5 to 10 days
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
From the moment of admission up until discharge after delivery, average 5 to 10 days
HELLP Syndrome
Time Frame: From the moment of admission up until discharge after delivery, average 5 to 10 days
Elevated liver enzymes Thrombocytopenia Hemolysis
From the moment of admission up until discharge after delivery, average 5 to 10 days
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
From the moment of admission up until delivery, average 5 to 10 days
Stillbirth
Time Frame: From the moment of admission up until discharge after delivery, average 5 to 10 days
Intrauterine fetal demise
From the moment of admission up until discharge after delivery, average 5 to 10 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-631

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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