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

Hypertension in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06403722
• Other study ID #: 2023-631
• Status: Completed
• Start date: November 15, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: May 2024
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: January 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced

Intervention

Diagnostic Test:
• Standard of care
No intervention. Clinical evolution was recorded, looking for perinatal complications.

Locations

Country	Name	City	State
Panama	Saint Thomas H	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kidney injury	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
Primary	Hepatic enzyme abnormalities	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
Primary	HELLP Syndrome	Elevated liver enzymes Thrombocytopenia Hemolysis	From the moment of admission up until discharge after delivery, average 5 to 10 days
Primary	Growth restricted fetus	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
Primary	Stillbirth	Intrauterine fetal demise	From the moment of admission up until discharge after delivery, average 5 to 10 days