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Completed

NCT Number: NCT06403722

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

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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Key information

Conditions

Hypertension in Pregnancy Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Saint Thomas H

Panama City, Panama

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard of care

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

  3. HELLP Syndrome

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

    Elevated liver enzymes Thrombocytopenia Hemolysis

  4. 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

  5. Stillbirth

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

    Intrauterine fetal demise

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

Perinatal Outcomes in Patients With Suspicion of Preeclampsia and Elevated sFlt-1/PlGF Before Term: A Retrospective Cohort Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 8, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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