Preeclampsia PossibleNCT06314555
Impact of the sFlt-1/PlGF Ratio on Medical Decision-making and on Maternal and Neonatal Outcomes in Women Suspected of Preeclampsia
An observational study of Preeclampsia Possible, 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
- Preeclampsia Possible
- What is being tested?
- Blood sample and Vascular-renal sample
- 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
- Adult, Older adult
Study population: Pregnant women suspected of preeclampsia, above 24 weeks of gestation.
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
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.
Read the detailed description
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 investigators observed the clinical decision regarding hospitalization, intensive patient monitoring, corticosteroid administration, and labor induction before and after knowing the ratio value.
- Conditions
- Preeclampsia Possible
- Being tested
- Blood sample, Vascular-renal sample
- Keywords
- Preeclampsia, Soluble fms-like tyrosine kinase, Placental growth factor, Medical care decision, Hospitalization
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood sample to analyse the values of sFlt-1 and PlGF
Vascular-renal sampleOther
Usual vascular-renal sample to analyse the values of sFlt-1 and PlGF
| Study group | Role | What they receive |
|---|---|---|
| Women under 37 weeks of gestation age | A woman with suspected preeclampsia and with inclusion criteria receives a blood sample, according to the department's usual practices, to analyse the values of sFlt-1 and PlGF and the usual vascular-renal sample. The woman gave her verbal consent to participate in the study. The Roche Elecsys® immunoassay sFlt-1/PlGF ratio was used to measure the two markers in the patients' blood. Receives: Other: Blood sample; Other: Vascular-renal sample | |
| Women above 37 weeks of gestation age | A woman with suspected preeclampsia and with inclusion criteria receives a blood sample, according to the department's usual practices, to analyse the values of sFlt-1 and PlGF and the usual vascular-renal sample. The woman gave her verbal consent to participate in the study. The Roche Elecsys® immunoassay sFlt-1/PlGF ratio was used to measure the two markers in the patients' blood. Receives: Other: Blood sample; Other: Vascular-renal sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doctor's medical care decisions on Hospitalization
Initial medical decision (hospitalization or no) was taken before knowing the test result. Revision of the medical decision occurred when the investigators had knowledge of the sFlt-1/PlGF result.
Measured: Day 1
Secondary outcomes (3)
Intensive monitoring
Intensive monitoring decision was taken before knowing the test result. Revision of the medical decision occurred when the investigators had knowledge of the sFlt-1/PlGF result.
Measured: Day 1
Corticosteroid administration for lung maturation
Corticosteroid administration for lung maturation decision was taken before knowing the test result. Revision of the medical decision occurred when the investigators had knowledge of the sFlt-1/PlGF result.
Measured: Day 1
Birth induction
Birth induction decision was taken before knowing the test result. Revision of the medical decision occurred when the investigators had knowledge of the sFlt-1/PlGF result.
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 posted18 Mar 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 Preeclampsia PossibleStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiphaine BARJAT, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314555
- Sponsor's protocol ID
- CEROG2023
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 18 Mar 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 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the sFlt-1/PlGF Ratio on Medical Decision-making and on Maternal and Neonatal Outcomes in Women Suspected of Preeclampsia
- ClinicalTrials.gov ID
- NCT06314555
- Acronym / sponsor ID
- CEROG2023
- Conditions
- Preeclampsia Possible
- Keywords
- Preeclampsia, Soluble fms-like tyrosine kinase, Placental growth factor, Medical care decision, Hospitalization
- 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
- 18 Mar 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.
Detailed description
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 investigators observed the clinical decision regarding hospitalization, intensive patient monitoring, corticosteroid administration, and labor induction before and after knowing the ratio value.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women under 37 weeks of gestation age | – | Other: Blood sample, Other: Vascular-renal sampleA woman with suspected preeclampsia and with inclusion criteria receives a blood sample, according to the department's usual practices, to analyse the values of sFlt-1 and PlGF and the usual vascular-renal sample. The woman gave her verbal consent to participate in the study. The Roche Elecsys® immunoassay sFlt-1/PlGF ratio was used to measure the two markers in the patients' blood. |
| Women above 37 weeks of gestation age | – | Other: Blood sample, Other: Vascular-renal sampleA woman with suspected preeclampsia and with inclusion criteria receives a blood sample, according to the department's usual practices, to analyse the values of sFlt-1 and PlGF and the usual vascular-renal sample. The woman gave her verbal consent to participate in the study. The Roche Elecsys® immunoassay sFlt-1/PlGF ratio was used to measure the two markers in the patients' blood. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Pregnant women suspected of preeclampsia, above 24 weeks of gestation.
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 |
|---|---|---|
| Blood sampleBlood sample to analyse the values of sFlt-1 and PlGF | Other | Women above 37 weeks of gestation age, Women under 37 weeks of gestation age |
| Vascular-renal sampleUsual vascular-renal sample to analyse the values of sFlt-1 and PlGF | Other | Women above 37 weeks of gestation age, Women under 37 weeks of gestation age |
Primary outcome
Doctor's medical care decisions on Hospitalization
Time frame: Day 1
Initial medical decision (hospitalization or no) was taken before knowing the test result. Revision of the medical decision occurred when the investigators had knowledge of the sFlt-1/PlGF result.
3 secondary outcomes
Intensive monitoring
Time frame: Day 1
Corticosteroid administration for lung maturation
Time frame: Day 1
Birth induction
Time frame: Day 1
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 18 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia Possible
RecruitingEarly Phase 1
Aspirin Dosing in Pregnancy
Preeclampsia Possible
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.
Tiphaine BARJAT, MD PhD principal investigator
Centre Hospitalier Universitaire 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 Preeclampsia Possible, 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 18 Mar 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?
Doctor's medical care decisions on Hospitalization (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 18 Mar 2024.