NCT06403722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

May 1, 2024

Last Update Submit

May 2, 2024

Conditions

Hypertension in Pregnancy

Keywords

Hypertension, pregnancy inducedAngiogenic factors

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • HELLP Syndrome

    Elevated liver enzymes Thrombocytopenia Hemolysis

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

  • 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

  • Stillbirth

    Intrauterine fetal demise

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

Study Arms (4)

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

Standard of careDIAGNOSTIC_TEST

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

sFlt-1/PlGF > 1000sFlt-1/PlGF: 110-205sFlt-1/PlGF: 206-654sFlt-1/PlGF: 655-999

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Gestational age below 23 6/7 weeks and above 37 weeks at the moment of admission.
  • Absence of sFLt-1/PlGF ratio result.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas H

Panama City, Panama

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the research deparment

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 8, 2024

Study Start

November 15, 2023

Primary Completion

December 30, 2023

Study Completion

January 30, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)