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CompletedNCT06403722Updated May 8, 2024

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

An observational study in Hypertension in Pregnancy, sponsored by Saint Thomas Hospital, Panama. Completed at 1 site in Panama. Open to female participants. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by Saint Thomas Hospital, Panama · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
190
Sex
Female
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Study 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. 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.

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Conditions studied

  • Hypertension in Pregnancy

Keywords

  • Hypertension, pregnancy induced
  • Angiogenic factors
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In context

Hypertension, Pregnancy-Induced

262 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 71 are open to participants now.

This study's enrollment of 190 is close to the median of 200 across 79 observational studies indexed under Hypertension, Pregnancy-Induced.

Browse Hypertension, Pregnancy-Induced studies →

Lead sponsor

Saint Thomas Hospital, Panama is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
190 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

Interventions

  • Diagnostic testStandard of care

    No intervention. Clinical evolution was recorded, looking for perinatal complications.

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What researchers measure

Primary outcomes

  1. Kidney injury

    Creatinine level \> 1.1 Doubling of creatinine levels when others causes had been excluded

    Time frame: From the moment of admission up until discharge after delivery, average 5 to 10 days

  2. Hepatic enzyme abnormalities

    Increase of liver enzyme to \> twice the upper limit of normal

    Time frame: From the moment of admission up until discharge after delivery, average 5 to 10 days

  3. HELLP Syndrome

    Elevated liver enzymes Thrombocytopenia Hemolysis

    Time frame: From the moment of admission up until discharge after delivery, average 5 to 10 days

  4. Growth restricted fetus

    Fetal weight below 10th percentile and abnormal doppler Fetal weight below 3th percentile

    Time frame: From the moment of admission up until delivery, average 5 to 10 days

  5. Stillbirth

    Intrauterine fetal demise

    Time frame: From the moment of admission up until discharge after delivery, average 5 to 10 days

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Study locations

1 site
  • Saint Thomas H
    Panama, Panama
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2023 to primary completion in Dec 2023, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2024
First posted
May 8, 2024
StartActual
Nov 15, 2023
Primary completionActual
Dec 30, 2023
CompletionActual
Jan 30, 2024
Last update
May 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06403722
Lead sponsor
Saint Thomas Hospital, Panama
Responsible party
Osvaldo A. Reyes T. (Head of the research deparment, Saint Thomas Hospital, Panama) — Principal investigator
First posted
May 8, 2024
Start date
Nov 15, 2023
Primary completion
Dec 30, 2023
Completion
Jan 30, 2024
Last update
May 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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