Blood test may cut unnecessary hospital stays for pre-eclampsia
NCT ID NCT05228002
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study looked at whether a blood test measuring the sFlt-1/PlGF ratio can help doctors decide if women with suspected pre-eclampsia need to be hospitalized. Pre-eclampsia is a serious pregnancy condition that can harm both mother and baby, but diagnosing it is tricky. The study involved 43 pregnant women and compared standard care to using the blood test results to guide decisions. The goal was to see if the test could reduce hospital stays without missing complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sFlt-1/PlGF ratio blood test
- What this could lead to
- If successful, this could lead to a simple blood test that helps doctors decide which women with suspected pre-eclampsia need hospital care, reducing unnecessary hospitalizations.
- What could go wrong
- This is a small, completed study with only 43 participants, so results may not apply broadly. The test is not yet standard practice, and more research is needed to confirm its benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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43 people
The number who actually took part.
- Started
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May 2023
- Finished
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Mar 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Nice University Hospital
Nice, France
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Other studies related to the condition(s) this trial covers.
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