Pre-EclampsiaNCT06224946
IMPACT OF THE BIOLOGICAL RATIO ON MEDICAL DECISION MAKING IN WOMEN SUSPECTED OF PREECLAMPSIA
An observational study of Pre-Eclampsia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Previous studies demonstrated that Placental Growth Factor (PIGF) and Vascular Endothelial Growth Factor (VEGF) produced by trophoblast cells decreases during Preeclampsia, whereas soluble fms-like tyrosine kinase-1 (sFlt-1), an antiangiogenic factor, increases. 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?
- soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio
- How many people
- 314 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 27 Jan 2021
- Phase
- Observational
- 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
Study population: 314 patients were included: 217 women under 37 weeks of gestation age and 97 women above this age.
Who may be able to join
- pregnant patients over 24 weeks of amenorrhea
- aged 18 and over
- with suspicion of preeclampsia defined by the appearance of pregnancy-induced hypertension (≥ 140 in systolic and/or 90 mmHg in diastolic pressure over 2 measurements at 4 hours intervals) OR proteinuria (≥ 0.3 g per 24 hours).
- who systematically gave oral consent after submitting the information sheet
Who cannot join
- pregnant women with both hypertension and proteinuria because they already have a confirmed diagnosis of preeclampsia.
- receiving antihypertensive treatment before pregnancy
- or refusing to participate in the study The sFlt-1/PlGF ratio was measured only when clinically indicated as per the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMPACT OF THE SOLUBLE LIKE TYROSINE KINASE/PLACENTAL GROWTH FACTOR RATIO ON MEDICAL DECISION-MAKING AND ON MATERNAL AND NEONATAL OUTCOMES IN WOMEN SUSPECTED OF PREECLAMPSIA
Previous studies demonstrated that Placental Growth Factor (PIGF) and Vascular Endothelial Growth Factor (VEGF) produced by trophoblast cells decreases during Preeclampsia, whereas soluble fms-like tyrosine kinase-1 (sFlt-1), an antiangiogenic factor, increases. The ratio sFlt-1/PlGF has a higher positive predictive value than the isolated measurement. A ratio under 38 exclude risk of imminent preeclampsia and allows to outpatient follow-up with a negative predictive value of 99.3%. A ratio equal or higher than 38 permits to direct high-risk patients towards hospitalization with a positive predictive value of 36.7% of preeclampsia at 4 weeks. These findings suggest that the ratio can be used to select more appropriately women needing hospitalization for suspected preeclampsia.
This is a single-center prospective and observational study conducted from the 1rst of October 2019 to the 27th of January 2021, including pregnant women suspected of preeclampsia, above 24 weeks of gestation. Values were measured using the Elecsys sFlt-1/PlGF immunoassay ratio. The aim of the study is to observe the clinical decision regarding hospitalization, intensive patient monitoring, corticosteroid administration, and labor induction before and after knowing the ratio value
- Conditions
- Pre-Eclampsia
- Being tested
- soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio
- Keywords
- Pre-Eclampsia, Placental Growth Factor, Soluble fms-like tyrosine Kinase, medical Care decision
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratioDiagnostic test
the soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio for pre-eclampsia diagnostic
| Study group | Role | What they receive |
|---|---|---|
| women under 37 weeks of gestation age | 217 women under 37 weeks of gestation age Receives: Diagnostic Test: soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio | |
| women above 37 weeks of gestation age | 97 women above 37 weeks of gestation age Receives: Diagnostic Test: soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
The soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio
Evaluate the impact of the soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio on medical decision-making in women with suspected preeclampsia in routine medical care.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Oct 2019
- Primary completion27 Jan 2021
- Study completion27 Jan 2021
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 Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BARJAT Tiphaine, MD, Principal investigator, CHU DE SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224946
- Sponsor's protocol ID
- CEROG 2022-OBS-0401
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT OF THE SOLUBLE LIKE TYROSINE KINASE/PLACENTAL GROWTH FACTOR RATIO ON MEDICAL DECISION-MAKING AND ON MATERNAL AND NEONATAL OUTCOMES IN WOMEN SUSPECTED OF PREECLAMPSIA
- ClinicalTrials.gov ID
- NCT06224946
- Acronym / sponsor ID
- CEROG 2022-OBS-0401
- Conditions
- Pre-Eclampsia
- Keywords
- Pre-Eclampsia, Placental Growth Factor, Soluble fms-like tyrosine Kinase, medical Care decision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 25 Jan 2024 (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.
Previous studies demonstrated that Placental Growth Factor (PIGF) and Vascular Endothelial Growth Factor (VEGF) produced by trophoblast cells decreases during Preeclampsia, whereas soluble fms-like tyrosine kinase-1 (sFlt-1), an antiangiogenic factor, increases. The ratio sFlt-1/PlGF has a higher positive predictive value than the isolated measurement. A ratio under 38 exclude risk of imminent preeclampsia and allows to outpatient follow-up with a negative predictive value of 99.3%. A ratio equal or higher than 38 permits to direct high-risk patients towards hospitalization with a positive predictive value of 36.7% of preeclampsia at 4 weeks. These findings suggest that the ratio can be used to select more appropriately women needing hospitalization for suspected preeclampsia.
This is a single-center prospective and observational study conducted from the 1rst of October 2019 to the 27th of January 2021, including pregnant women suspected of preeclampsia, above 24 weeks of gestation. Values were measured using the Elecsys sFlt-1/PlGF immunoassay ratio. The aim of the study is to observe the clinical decision regarding hospitalization, intensive patient monitoring, corticosteroid administration, and labor induction before and after knowing the ratio value
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women under 37 weeks of gestation age | – | Diagnostic Test: soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio217 women under 37 weeks of gestation age |
| women above 37 weeks of gestation age | – | Diagnostic Test: soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio97 women above 37 weeks of gestation age |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 314 patients were included: 217 women under 37 weeks of gestation age and 97 women above this age.
Key inclusion criteria (4 listed)
- pregnant patients over 24 weeks of amenorrhea
- aged 18 and over
- with suspicion of preeclampsia defined by the appearance of pregnancy-induced hypertension (≥ 140 in systolic and/or 90 mmHg in diastolic pressure over 2 measurements at 4 hours intervals) OR proteinuria (≥ 0.3 g per 24 hours).
- who systematically gave oral consent after submitting the information sheet
Key exclusion criteria (3 listed)
- pregnant women with both hypertension and proteinuria because they already have a confirmed diagnosis of preeclampsia.
- receiving antihypertensive treatment before pregnancy
- or refusing to participate in the study The sFlt-1/PlGF ratio was measured only when clinically indicated as per the investigator's judgment.
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 |
|---|---|---|
| soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratiothe soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio for pre-eclampsia diagnostic | Diagnostic test | women above 37 weeks of gestation age, women under 37 weeks of gestation age |
Primary outcome
The soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio
Time frame: day 1
Evaluate the impact of the soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio on medical decision-making in women with suspected preeclampsia in routine medical care.
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 25 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Pre-Eclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
BARJAT Tiphaine, MD principal investigator
CHU DE SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 3 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 25 Jan 2024. 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?
The soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio (time frame: day 1). 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 25 Jan 2024.