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sFlt-1/PlGF Ratio: Impact on the Management of Patients With Suspected Pre-eclampsia (PROSPE)

Primary Purpose

Pre-Eclampsia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sFlt-1/PlGF ratio - Active Comparator: Standard
sFlt-1/PlGF ratio - Experimental: Biomarkers
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pre-Eclampsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant patient
  • Affiliated to the Social Security
  • Signature of informed consent
  • Term > 24 week of amenorrhea and < 37 week of amenorrhea
  • Presence of at least 2 of the following signs: de novo hypertension (Systolic Blood Pressure ≥ 140 mmHg and/or Diastolic Blood Pressure ≥ 90 mmHg) or worsening of pre-existing hypertension (increase of more than 10 mmHg in usual Systolic Blood Pressure and/or Diastolic Blood Pressure)

    • De novo proteinuria onset (24h proteinuria ≥ 0.3 g/24h or proteinuria/creatinuria ratio ≥ 0.3) or worsening of pre-existing proteinuria
    • Criteria for clinical suspicion of pre-eclampsia: epigastric pain, excessive edema, headache, visual disturbances, sudden weight gain (> 1kg/week in the 3rd trimester)
    • Biological signs related to pre-eclampsia: low platelet count (thrombocytopenia < 150 G/L), liver cytolysis (AST and/or ALT AST greater than 2 times normal)
    • Suspicion of intrauterine growth retardation on obstetrical ultrasound with no other cause found

Exclusion Criteria:

  • Minor patient
  • Patient with poor clinical tolerance of hypertension and/or need for immediate introduction of intravenous antihypertensive therapy
  • Patient with a specific complication of pre-eclampsia requiring immediate management at the time of inclusion: in utero fetal death, retroplacental hematoma, disseminated intravascular coagulation or emergency cesarean section.
  • Vulnerable person requiring enhanced protection, i.e., relatively (or totally) unable to protect their own interests. Specifically, the person's power, intelligence, education, resources, strength, or other attributes necessary to protect his or her own interests may be inadequate (e.g., persons deprived of liberty, minors, persons under guardianship, persons with mental or emotional disabilities in the broadest sense of the word, illiterate persons, refugees and asylum seekers, alcoholics and drug addicts, etc.)

Sites / Locations

  • Nice University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard

Biomarkers

Arm Description

The monitoring criteria used will be the same as those usually used at the Nice University Hospital, according to the protocol of the department. For patients in the "standard" group, the biomarker results will be masked and then revealed afterwards for statistical analysis.

The monitoring decision will be made based on the ratio calculation: Ratio < 38: "Classic" monitoring with one prenatal visit per month 38 ≤ Ratio ≤ 85: Close outpatient monitoring Ratio > 85: Inpatient monitoring in Pathological Pregnancy

Outcomes

Primary Outcome Measures

hospitalization rate
hospitalization rate for each group.

Secondary Outcome Measures

sFlt-1/PlGF ratio at inclusion and length of hospital stay
correlation between sFlt-1/PlGF ratio at inclusion and length of hospital stay
Complications specific to pre-eclampsia
occurrence of complications specific to pre-eclampsia (eclampsia, HELLP-syndrome, fetal death in utero...)
Pregnancy Outcome
Correlation of the sFlt-1/PlGF ratio at inclusion and its kinetics with pregnancy outcome (route of delivery and urgency criteria)
newborn health status at birth
Correlation of the sFlt-1/PlGF ratio at inclusion and its kinetics with newborn health status at birth (Apgar score and need for immediate pediatric management)

Full Information

First Posted
January 27, 2022
Last Updated
June 13, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05228002
Brief Title
sFlt-1/PlGF Ratio: Impact on the Management of Patients With Suspected Pre-eclampsia
Acronym
PROSPE
Official Title
sFlt-1/PlGF Ratio: Impact on the Management of Patients With Suspected Pre-eclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pre-eclampsia is a specific pathology of pregnancy classically associating arterial hypertension with proteinuria. Its prevalence in industrialized countries is 3 to 8% of pregnancies, which makes it a frequent pathology, and it is responsible for 30% of premature deliveries. The consequences of this pathology can be very serious for the mother:renal insufficiency, hepatic cytolysis, retro-capsular hematoma of the liver, convulsions, disseminated intravascular coagulation. Moreover, the consequences on the fetus and the pregnancy are just as serious: intrauterine growth retardation, induced prematurity, retroplacental hematoma, fetal death in utero. Pre-eclampsia therefore remains difficult to diagnose and to prognose. The diagnosis of pre-eclampsia based on blood pressure and proteinuria has a predictive value of 30% for adverse outcomes related to pre-eclampsia. In recent years, new biomarkers have been studied: PlGF, a placental growth factor, and sFlt-1, the free fraction of its membrane receptor.The pathophysiology and specificity of these biomarkers, but especially their ratio, has been widely studied and demonstrated in the diagnosis and prognosis of preeclampsia. Nevertheless, few studies have analyzed the impact of this report on the hospitalization of patients, except mainly a German study which showed a change in the decision to hospitalize in 16.9% of cases. On the other hand, no French study has been carried out on this subject. Finally, no professional recommendation fully integrates or clearly frames the use of the ratio in current practice. Its use therefore remains disparate between countries, but also within the same country, as in France, where few centers use it. The decision to hospitalize a patient with suspected preeclampsia depends on the organization of the health care system. It therefore seems interesting to analyze the precise impact on hospitalizations of the use of a diagnostic and prognostic tool such as the sFlt-1/PlGF ratio with the specificities of the French health system, which favors outpatient management.The study would evaluate the use of this promising tool in the daily management of parturients, paving the way for the development of simple recommendations applicable in the various French maternity hospitals. The hypothesis is that the use of the sFlt-1/PlGF ratio in patients with suspected pre-eclampsia would reduce the rate of hospitalization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
The monitoring criteria used will be the same as those usually used at the Nice University Hospital, according to the protocol of the department. For patients in the "standard" group, the biomarker results will be masked and then revealed afterwards for statistical analysis.
Arm Title
Biomarkers
Arm Type
Experimental
Arm Description
The monitoring decision will be made based on the ratio calculation: Ratio < 38: "Classic" monitoring with one prenatal visit per month 38 ≤ Ratio ≤ 85: Close outpatient monitoring Ratio > 85: Inpatient monitoring in Pathological Pregnancy
Intervention Type
Other
Intervention Name(s)
sFlt-1/PlGF ratio - Active Comparator: Standard
Intervention Description
Blood test for biomarkers (sFlt-1/PlGF ratio) For patients in the "standard" group, the biomarker results will be masked and then revealed afterwards for statistical analysis. For the "biomarkers" group, the monitoring decision will be made based on the ratio calculation
Intervention Type
Other
Intervention Name(s)
sFlt-1/PlGF ratio - Experimental: Biomarkers
Intervention Description
Blood test for biomarkers (sFlt-1/PlGF ratio) For patients in the "standard" group, the biomarker results will be masked and then revealed afterwards for statistical analysis. For the "biomarkers" group, the monitoring decision will be made based on the ratio calculation.
Primary Outcome Measure Information:
Title
hospitalization rate
Description
hospitalization rate for each group.
Time Frame
up to 4 months
Secondary Outcome Measure Information:
Title
sFlt-1/PlGF ratio at inclusion and length of hospital stay
Description
correlation between sFlt-1/PlGF ratio at inclusion and length of hospital stay
Time Frame
up to 4 months
Title
Complications specific to pre-eclampsia
Description
occurrence of complications specific to pre-eclampsia (eclampsia, HELLP-syndrome, fetal death in utero...)
Time Frame
up to 4 months
Title
Pregnancy Outcome
Description
Correlation of the sFlt-1/PlGF ratio at inclusion and its kinetics with pregnancy outcome (route of delivery and urgency criteria)
Time Frame
up to 4 months
Title
newborn health status at birth
Description
Correlation of the sFlt-1/PlGF ratio at inclusion and its kinetics with newborn health status at birth (Apgar score and need for immediate pediatric management)
Time Frame
up to 4 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant patient Affiliated to the Social Security Signature of informed consent Term > 24 week of amenorrhea and < 37 week of amenorrhea Presence of at least 2 of the following signs: de novo hypertension (Systolic Blood Pressure ≥ 140 mmHg and/or Diastolic Blood Pressure ≥ 90 mmHg) or worsening of pre-existing hypertension (increase of more than 10 mmHg in usual Systolic Blood Pressure and/or Diastolic Blood Pressure) De novo proteinuria onset (24h proteinuria ≥ 0.3 g/24h or proteinuria/creatinuria ratio ≥ 0.3) or worsening of pre-existing proteinuria Criteria for clinical suspicion of pre-eclampsia: epigastric pain, excessive edema, headache, visual disturbances, sudden weight gain (> 1kg/week in the 3rd trimester) Biological signs related to pre-eclampsia: low platelet count (thrombocytopenia < 150 G/L), liver cytolysis (AST and/or ALT AST greater than 2 times normal) Suspicion of intrauterine growth retardation on obstetrical ultrasound with no other cause found Exclusion Criteria: Minor patient Patient with poor clinical tolerance of hypertension and/or need for immediate introduction of intravenous antihypertensive therapy Patient with a specific complication of pre-eclampsia requiring immediate management at the time of inclusion: in utero fetal death, retroplacental hematoma, disseminated intravascular coagulation or emergency cesarean section. Vulnerable person requiring enhanced protection, i.e., relatively (or totally) unable to protect their own interests. Specifically, the person's power, intelligence, education, resources, strength, or other attributes necessary to protect his or her own interests may be inadequate (e.g., persons deprived of liberty, minors, persons under guardianship, persons with mental or emotional disabilities in the broadest sense of the word, illiterate persons, refugees and asylum seekers, alcoholics and drug addicts, etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie ANTOMARCHI
Phone
04 92 03 60 92
Ext
+33
Email
antomarchi.j@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gary BORREL
Phone
04 92 03 60 92
Ext
+33
Email
garyborrel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie ANTOMARCHI
Organizational Affiliation
Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nice University Hospital
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie ANTOMARCHI
Phone
04 92 03 60 92
Ext
+33
Email
antomarchi.j@chu-nice.fr

12. IPD Sharing Statement

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sFlt-1/PlGF Ratio: Impact on the Management of Patients With Suspected Pre-eclampsia

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