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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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)

November 15, 2023

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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