Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-06 @ 9:11 PM
Study NCT ID:
NCT04170660
Status:
UNKNOWN
Last Update Posted:
2023-06-07
First Post:
2019-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of sFlt1/PlGF Ratio at Obstetric Emergencies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003955', 'term': 'Diagnostic Tests, Routine'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2019-11-15', 'studyFirstSubmitQcDate': '2019-11-19', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reconvening period in patients with an sFlt1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor) ratio <38 (day)', 'timeFrame': 'trough participation period, an average of 4 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'reconvening period in patients with an sFlt1/PlGF ratio between 38 and 85 (day)', 'timeFrame': 'trough participation period, an average of 4 months', 'description': 'rate of reconvening'}, {'measure': 'reconvening period in patients with an sFlt1/PlGF ratio superior to 85 (day)', 'timeFrame': 'trough participation period, an average of 4 months', 'description': 'rate of reconvening'}, {'measure': 'blood pressure (mmHg)', 'timeFrame': 'trough participation period, an average of 4 months', 'description': 'Blood pressure higher than 140/90 mm Hg'}, {'measure': 'number of patients with functional signs of hypertension', 'timeFrame': 'trough participation period, an average of 4 months', 'description': 'phosphenes, accouphens, headaches, epigastric bar, edema'}, {'measure': 'number of patient with abnormal vascular and renal blood tests', 'timeFrame': 'trough participation period, an average of 4 months', 'description': 'platelets, transaminase, uric acid, ionogram'}, {'measure': 'proteinuria (mg/mmol)', 'timeFrame': 'trough participation period, an average of 4 months', 'description': 'urine protein-creatinine (P/C) ratio, mg/mmol'}, {'measure': 'Intra Uterine growth restriction (IUGR)', 'timeFrame': 'trough participation period, an average of 4 months', 'description': 'estimate foetal weight \\< 10 percentile or \\< 5 percentile'}, {'measure': 'fetal echography', 'timeFrame': 'trough participation period, an average of 4 months', 'description': 'umbilical and/or cerebral doppler'}, {'measure': 'term of delivery (weeks of gestation)', 'timeFrame': 'at birth', 'description': 'Analysis of term delivery with stratification by sFlt-1/PlGF ratio'}, {'measure': 'fetal weight at birth (g)', 'timeFrame': 'at birth', 'description': 'Analysis of fetal weight with stratification by sFlt-1/PlGF ratio'}, {'measure': 'number of hospitalized new born', 'timeFrame': 'at birth', 'description': 'Analysis of number of hospitalized new born with stratification by sFlt-1/PlGF ratio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suspected Placental Dysfunction, Ruled Out', 'Pregnancy Complications', 'Pre-Eclampsia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe sFlt-1/ PlGF assay has a high negative predictive value for the coming week.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women suspected of placental vascular disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Pregnant patients term ≥ at 24 weeks of amenorrhoea (SA),\n* 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).\n* Presenting either one of the following isolated or associated clinical parameters:\n* HyperTension\n* urinary tape proteinuria\n* functional signs of hypertension (headaches, phosphenes, accouphènes)\n* live osteotendinous reflexes\n* epigastric pains\n* weight gain, lower limb edema, facial edema\n* oliguria\n* vomiting\n* or one of the following isolated or associated ultrasound parameters:\n* fetal hypotrophy, fetal growth deflection\n* fetal Doppler abnormalities (umbilical Doppler, cerebral Doppler)\n* ooligo-anamnios with intact membranes\n* patient who has been informed and has given her oral non-opposition\n\nExclusion Criteria:\n\n* Diagnosis of preeclampsia\n* Refusal of the patient\n* Patient whose symptomatology (clinical or paraclinical) leads to a decision to be hospitalized\n* Age \\< 18 years old\n* Non-affiliation to the general social security system'}, 'identificationModule': {'nctId': 'NCT04170660', 'acronym': 'AngioCHIC', 'briefTitle': 'Interest of sFlt1/PlGF Ratio at Obstetric Emergencies', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'AngioCHIC : Interest of sFlt1/PlGF Ratio at Obstetric Emergencies', 'orgStudyIdInfo': {'id': 'AngioCHIC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Diagnostic test', 'type': 'DIAGNOSTIC_TEST', 'description': 'During a vascular check-up usually prescribed, an additional blood sample is taken to allow the determination of the sFlt1/PlGf ratio.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal de Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}