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

Completed

• Conditions: Hypertension in Pregnancy
• Interventions: Diagnostic Test: Standard of care

• Registration Number: NCT06403722
• Lead Sponsor: Saint Thomas Hospital, Panama

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-15
• Primary Completion: 2023-12-30
• Study Completion: 2024-01-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 190

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sFlt-1/PlGF: 206-654	Standard of care	Subjects with suspicion of preeclampsia, with gestational age between 24 - 36 6/7 weeks and sFlt-1/PlGF between 206-654.
sFlt-1/PlGF > 1000	Standard of care	Subjects with suspicion of preeclampsia, with gestational age between 24 - 36 6/7 weeks and sFlt-1/PlGF above 1000.
sFlt-1/PlGF: 110-205	Standard of care	Subjects with suspicion of preeclampsia, with gestational age between 24 - 36 6/7 weeks and sFlt-1/PlGF between 110-205.
sFlt-1/PlGF: 655-999	Standard of care	Subjects with suspicion of preeclampsia, with gestational age between 24 - 36 6/7 weeks and sFlt-1/PlGF between 655-999.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Saint Thomas H; 🇵🇦 Panama, Panama