Pre-EclampsiaPROSPENCT05228002
sFlt-1/PlGF Ratio: Impact on the Management of Patients With Suspected Pre-eclampsia
A study testing sFlt-1/PlGF ratio - Active Comparator: Standard and sFlt-1/PlGF ratio - Experimental: Biomarkers in people with Pre-Eclampsia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- sFlt-1/PlGF ratio - Active Comparator: Standard and sFlt-1/PlGF ratio - Experimental: Biomarkers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2023to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant patient
- Affiliated to the Social Security
- Signature of informed consent
- Term > 24 week of amenorrhea and < 37 week of amenorrhea
- Single criterion among the following: (only one box below must be ticked to allow inclusion):
- de novo hypertension (PAS ≥ 140 mmHg and/or PAD ≥ 90 mmHg) ;
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- worsening of pre-existing hypertension >10 mmHg (on PAS or PAD ) ;
- worsening of pre-existing proteinuria;
- Excessive edema AND significant weight gain (minimum 2kg/week);
- Headache AND another clinical sign (edema, rapid weight gain);
- Visual disturbances (phosphenes and/or visual blur) AND/OR tinnitus;
- Sudden weight gain (> 1kg/week during the 3rd trimester);
- Low platelet count (thrombocytopenia < 150 G/L);
- Hepatic cytolysis (ASAT and/or ALAT > 2N) without associated pruritus or jaundice;
- Suspicion of intrauterine growth retardation on obstetric ultrasound, with no other cause found (no hypertension or proteinuria, no clinical or biological signs of pre-eclampsia) and no abnormal fetal dopplers.
Who cannot join
- 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.
- Association of at least 2 of the following criteria:
- De novo proteinuria (24h proteinuria ≥ 0.3 g/24h or P/C ratio ≥ 0.3) or worsening of pre- existing proteinuria;
- Criteria for clinical suspicion of pre-eclampsia: epigastric pain, excessive edema, headaches, visual disturbances, sudden weight gain (> 1kg/week in the 3rd trimester);
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- Biological signs associated with pre-eclampsia: low platelet count (thrombocytopenia < 150 G/L), hepatic cytolysis (ASAT and/or ALAT > 2N);
- Suspicion of intrauterine growth retardation on obstetrical ultrasound, with no other cause found.
- A combination of at least 2 of these criteria raises the suspicion of pre-eclampsia, and, according to the new CNGOF recommendations of 2024, requires systematic initial hospitalization.
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Pre-Eclampsia
- Being tested
- sFlt-1/PlGF ratio - Active Comparator: Standard, sFlt-1/PlGF ratio - Experimental: Biomarkers
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sFlt-1/PlGF ratio - Active Comparator: StandardOther
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
sFlt-1/PlGF ratio - Experimental: BiomarkersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | 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. Receives: Other: sFlt-1/PlGF ratio - Active Comparator: Standard |
| Biomarkers | Experimental | 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 Receives: Other: sFlt-1/PlGF ratio - Experimental: Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospitalization rate
hospitalization rate for each group.
Measured: up to 4 months
Secondary outcomes (4)
sFlt-1/PlGF ratio at inclusion and length of hospital stay
correlation between sFlt-1/PlGF ratio at inclusion and length of hospital stay
Measured: up to 4 months
Complications specific to pre-eclampsia
occurrence of complications specific to pre-eclampsia (eclampsia, HELLP-syndrome, fetal death in utero...)
Measured: up to 4 months
Pregnancy Outcome
Correlation of the sFlt-1/PlGF ratio at inclusion and its kinetics with pregnancy outcome (route of delivery and urgency criteria)
Measured: up to 4 months
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)
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start23 May 2023
- Primary completion3 Mar 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie ANTOMARCHI, Principal investigator, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228002
- Sponsor's protocol ID
- 19-AOI-02
- Acronym
- PROSPE
- Status last verified
- Sep 2025
- First submitted
- 27 Jan 2022
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- sFlt-1/PlGF Ratio: Impact on the Management of Patients With Suspected Pre-eclampsia
- ClinicalTrials.gov ID
- NCT05228002
- Acronym / sponsor ID
- PROSPE / 19-AOI-02
- Conditions
- Pre-Eclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Other: sFlt-1/PlGF ratio - Active Comparator: StandardThe 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. |
| Biomarkers | Experimental | Other: sFlt-1/PlGF ratio - Experimental: BiomarkersThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Pregnant patient
- Affiliated to the Social Security
- Signature of informed consent
- Term > 24 week of amenorrhea and < 37 week of amenorrhea
- Single criterion among the following: (only one box below must be ticked to allow inclusion):
Key exclusion criteria (10 listed)
- 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.
- Association of at least 2 of the following criteria:
- A combination of at least 2 of these criteria raises the suspicion of pre-eclampsia, and, according to the new CNGOF recommendations of 2024, requires systematic initial hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sFlt-1/PlGF ratio - Active Comparator: StandardBlood 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 | Other | Standard |
| sFlt-1/PlGF ratio - Experimental: BiomarkersBlood 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. | Other | Biomarkers |
Primary outcome
hospitalization rate
Time frame: up to 4 months
hospitalization rate for each group.
4 secondary outcomes
sFlt-1/PlGF ratio at inclusion and length of hospital stay
Time frame: up to 4 months
Complications specific to pre-eclampsia
Time frame: up to 4 months
Pregnancy Outcome
Time frame: up to 4 months
newborn health status at birth
Time frame: up to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie ANTOMARCHI principal investigator
Nice University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sFlt-1/PlGF ratio - Active Comparator: Standard and sFlt-1/PlGF ratio - Experimental: Biomarkers in people with Pre-Eclampsia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospitalization rate (time frame: up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.