Impact of sFlt-1/PlGF Ratio on Managing Suspected Pre-eclampsia

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

This study is testing if a new blood test can help doctors better manage pregnant women who might have pre-eclampsia, a condition that raises blood pressure and can be dangerous for both mom and baby.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Centre Hospitalier Universitaire de Nice (Academic / other)
• Locations: 1 site (Nice)
• Trial ID: NCT05228002 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of the sFlt-1/PlGF ratio as a diagnostic tool for managing patients with suspected pre-eclampsia, a serious pregnancy complication characterized by high blood pressure and protein in the urine. The study compares the use of this biomarker ratio against standard diagnostic methods to improve prediction and management of adverse outcomes associated with pre-eclampsia. By enrolling pregnant patients who meet specific criteria, the trial aims to provide insights into the utility of these biomarkers in clinical practice.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women between 24 and 37 weeks of gestation who exhibit signs of hypertension or other related symptoms.

Not a fit: Patients who are not pregnant or those who do not exhibit any symptoms related to pre-eclampsia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of pre-eclampsia diagnosis and improve maternal and fetal outcomes.

How similar studies have performed: Other studies have explored the use of biomarkers in diagnosing pre-eclampsia, showing promising results, but this specific approach is still being evaluated.

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
* 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) ;
  * 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.

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.
* 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);
  * 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.)

Where this trial is running

Nice

• Nice University Hospital — Nice, France (Recruiting)

Study contacts

• Principal investigator: Julie ANTOMARCHI — Nice University Hospital
• Study coordinator: Julie ANTOMARCHI

Conditions Pre-Eclampsia