Suspected Placental Dysfunction, Ruled OutAngioCHICNCT04170660
Interest of sFlt1/PlGF Ratio at Obstetric Emergencies
An observational study of Suspected Placental Dysfunction, Ruled Out and Pregnancy Complications, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
In patients with suspected placental vascular disease who do not require hospitalization, the use of the sFlt-1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor)/ assay can most likely help teams to define the best possible management. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Suspected Placental Dysfunction, Ruled Out, Pregnancy Complications, Pre-Eclampsia
- What is being tested?
- Diagnostic test
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2019to Dec 2023
- 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: pregnant women suspected of placental vascular disease
Who may be able to join
- Age ≥ 18 years old
- Pregnant patients term ≥ at 24 weeks of amenorrhoea (SA),
- Management in obstetrical emergencies and at the Centre Hopsitalier Intercommunal (CHI) de Créteil functional exploration center, with prescription of a vascular-renal check-up (BVR) ((proteinuria/creatinuria ratio, blood count, platelets, blood ionogram, creatinemia, transaminases (ASAT, ALAT), haptoglobulinemia, lactate dehydrogenase (LDH), TP).
- Presenting either one of the following isolated or associated clinical parameters:
- HyperTension
- urinary tape proteinuria
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- functional signs of hypertension (headaches, phosphenes, accouphènes)
- live osteotendinous reflexes
- epigastric pains
- weight gain, lower limb edema, facial edema
- oliguria
- vomiting
- or one of the following isolated or associated ultrasound parameters:
- fetal hypotrophy, fetal growth deflection
- fetal Doppler abnormalities (umbilical Doppler, cerebral Doppler)
- ooligo-anamnios with intact membranes
- patient who has been informed and has given her oral non-opposition
Who cannot join
- Diagnosis of preeclampsia
- Refusal of the patient
- Patient whose symptomatology (clinical or paraclinical) leads to a decision to be hospitalized
- Age < 18 years old
- Non-affiliation to the general social security system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AngioCHIC : Interest of sFlt1/PlGF Ratio at Obstetric Emergencies
In patients with suspected placental vascular disease who do not require hospitalization, the use of the sFlt-1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor)/ assay can most likely help teams to define the best possible management.
Read the detailed description
Preeclampsia is a serious obstetric condition, affecting 2 to 5% of pregnancies and associated with maternal hypertension and renal dysfunction. It is a constant concern of obstetrical teams in the pre and post partum period. In case of diagnosis in the emergency unit, patients are usually hospitalized. However, in the case of a diagnosis of preeclampsia has been invalidated, but in presence of isolated or frustrated clinical functional signs, in the case of a history of placental vascular pathology, obstetric teams implement surveillance strategies that are binding on the patients.
The sFlt-1/ PlGF assay has a high negative predictive value for the coming week.
The use in clinical practice of these two biomarkers in the indication of negative prediction at one week could help teams in their management but the interest of this use needs to be evaluated.
- Being tested
- Diagnostic test
- Medical subject headings
- Pregnancy Complications, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testDiagnostic test
During a vascular check-up usually prescribed, an additional blood sample is taken to allow the determination of the sFlt1/PlGf ratio.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reconvening period in patients with an sFlt1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor) ratio <38 (day)
At the end of pregnancy, calculation of the average time between the 1st consultation and the 1st reconvening in patients with an sFlt1/PlGF ratio <38, unknown during pregnancy, to determine if consultations could have been avoided.
Measured: trough participation period, an average of 4 months
Secondary outcomes (11)
reconvening period in patients with an sFlt1/PlGF ratio between 38 and 85 (day)
rate of reconvening
Measured: trough participation period, an average of 4 months
reconvening period in patients with an sFlt1/PlGF ratio superior to 85 (day)
rate of reconvening
Measured: trough participation period, an average of 4 months
blood pressure (mmHg)
Blood pressure higher than 140/90 mm Hg
Measured: trough participation period, an average of 4 months
number of patients with functional signs of hypertension
phosphenes, accouphens, headaches, epigastric bar, edema
Measured: trough participation period, an average of 4 months
number of patient with abnormal vascular and renal blood tests
platelets, transaminase, uric acid, ionogram
Measured: trough participation period, an average of 4 months
proteinuria (mg/mmol)
urine protein-creatinine (P/C) ratio, mg/mmol
Measured: trough participation period, an average of 4 months
Intra Uterine growth restriction (IUGR)
estimate foetal weight < 10 percentile or < 5 percentile
Measured: trough participation period, an average of 4 months
fetal echography
umbilical and/or cerebral doppler
Measured: trough participation period, an average of 4 months
term of delivery (weeks of gestation)
Analysis of term delivery with stratification by sFlt-1/PlGF ratio
Measured: at birth
fetal weight at birth (g)
Analysis of fetal weight with stratification by sFlt-1/PlGF ratio
Measured: at birth
number of hospitalized new born
Analysis of number of hospitalized new born with stratification by sFlt-1/PlGF ratio
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start18 Nov 2019
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected Placental Dysfunction, Ruled OutStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170660
- Sponsor's protocol ID
- AngioCHIC
- Acronym
- AngioCHIC
- Status last verified
- Jun 2023
- First submitted
- 15 Nov 2019
- Last updated
- 7 Jun 2023
- 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 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AngioCHIC : Interest of sFlt1/PlGF Ratio at Obstetric Emergencies
- ClinicalTrials.gov ID
- NCT04170660
- Acronym / sponsor ID
- AngioCHIC / AngioCHIC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Nov 2019 (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.
In patients with suspected placental vascular disease who do not require hospitalization, the use of the sFlt-1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor)/ assay can most likely help teams to define the best possible management.
Detailed description
Preeclampsia is a serious obstetric condition, affecting 2 to 5% of pregnancies and associated with maternal hypertension and renal dysfunction. It is a constant concern of obstetrical teams in the pre and post partum period. In case of diagnosis in the emergency unit, patients are usually hospitalized. However, in the case of a diagnosis of preeclampsia has been invalidated, but in presence of isolated or frustrated clinical functional signs, in the case of a history of placental vascular pathology, obstetric teams implement surveillance strategies that are binding on the patients.
The sFlt-1/ PlGF assay has a high negative predictive value for the coming week.
The use in clinical practice of these two biomarkers in the indication of negative prediction at one week could help teams in their management but the interest of this use needs to be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women suspected of placental vascular disease
Key inclusion criteria (17 listed)
- Age ≥ 18 years old
- Pregnant patients term ≥ at 24 weeks of amenorrhoea (SA),
- Management in obstetrical emergencies and at the Centre Hopsitalier Intercommunal (CHI) de Créteil functional exploration center, with prescription of a vascular-renal check-up (BVR) ((proteinuria/creatinuria ratio, blood count, platelets, blood ionogram, creatinemia, transaminases (ASAT, ALAT), haptoglobulinemia, lactate dehydrogenase (LDH), TP).
- Presenting either one of the following isolated or associated clinical parameters:
- HyperTension
Key exclusion criteria (5 listed)
- Diagnosis of preeclampsia
- Refusal of the patient
- Patient whose symptomatology (clinical or paraclinical) leads to a decision to be hospitalized
- Age < 18 years old
- Non-affiliation to the general social security system
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 |
|---|---|---|
| Diagnostic testDuring a vascular check-up usually prescribed, an additional blood sample is taken to allow the determination of the sFlt1/PlGf ratio. | Diagnostic test | – |
Primary outcome
Reconvening period in patients with an sFlt1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor) ratio <38 (day)
Time frame: trough participation period, an average of 4 months
At the end of pregnancy, calculation of the average time between the 1st consultation and the 1st reconvening in patients with an sFlt1/PlGF ratio <38, unknown during pregnancy, to determine if consultations could have been avoided.
11 secondary outcomes
reconvening period in patients with an sFlt1/PlGF ratio between 38 and 85 (day)
Time frame: trough participation period, an average of 4 months
reconvening period in patients with an sFlt1/PlGF ratio superior to 85 (day)
Time frame: trough participation period, an average of 4 months
blood pressure (mmHg)
Time frame: trough participation period, an average of 4 months
number of patients with functional signs of hypertension
Time frame: trough participation period, an average of 4 months
number of patient with abnormal vascular and renal blood tests
Time frame: trough participation period, an average of 4 months
proteinuria (mg/mmol)
Time frame: trough participation period, an average of 4 months
Intra Uterine growth restriction (IUGR)
Time frame: trough participation period, an average of 4 months
fetal echography
Time frame: trough participation period, an average of 4 months
term of delivery (weeks of gestation)
Time frame: at birth
fetal weight at birth (g)
Time frame: at birth
number of hospitalized new born
Time frame: at birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Suspected Placental Dysfunction, Ruled Out and Pregnancy Complications, run by Centre Hospitalier Intercommunal Creteil 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 17 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Jun 2023. 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?
Results are not available in the source record.
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?
Reconvening period in patients with an sFlt1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor) ratio <38 (day) (time frame: trough participation period, an average of 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 7 Jun 2023.