[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635004":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":35,"studyPopulation":36,"armGroups":31,"interventions":31,"overallOfficials":31,"centralContacts":37,"locations":44,"responsibleParty":208,"collaborators":31,"id":210,"slug":31,"hasResults":211,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":211,"sex":217,"minAge":218,"maxAge":31,"enrollmentInfo":219,"targetDuration":31,"studyType":222,"phases":31,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":233,"whyStopped":31,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Failure of blood pressure control with intravenous labetalol monotherapy","Composite outcome defined as failure to achieve blood pressure control with intravenous labetalol monotherapy in patients with severe preeclampsia. Failure is defined by the occurrence of at least one of the following: addition or switch to another antihypertensive treatment; persistence of severe hypertension after four intravenous labetalol boluses; persistence of hypertension despite continuous intravenous labetalol infusion at the maximum dose of 1 mg\u002Fkg\u002Fh; or occurrence of a complication attributable to inadequate blood pressure control (e.g., stroke, eclampsia, pulmonary edema, maternal or neonatal death).","During the first hour following initiation of intravenous labetalol administration",[14,17,20,24,28],{"measure":15,"description":16,"timeFrame":12},"Adverse effects related to intravenous labetalol","Occurrence of adverse events potentially related to labetalol administration, including allergic reactions, bronchospasm, and neonatal hypoglycemia.",{"measure":18,"description":19,"timeFrame":12},"Safety of intravenous labetalol administration","Occurrence of safety events defined as maternal hypotension (systolic blood pressure \\\u003C 90 mmHg, diastolic blood pressure \\\u003C 60 mmHg, or mean arterial pressure \\\u003C 65 mmHg) and\u002For maternal bradycardia (heart rate \\\u003C 50 beats per minute).",{"measure":21,"description":22,"timeFrame":23},"Maternal and fetal morbidity and mortality","Occurrence of maternal and fetal complications related to severe preeclampsia or inadequate blood pressure control, including stroke, eclampsia, intracranial hemorrhage, placental abruption, intrauterine fetal death, posterior reversible encephalopathy syndrome, reversible cerebral vasoconstriction syndrome, pulmonary edema, maternal death, or neonatal death.","From initiation of intravenous labetalol treatment until hospital discharge (up to 7 days)",{"measure":25,"description":26,"timeFrame":27},"Predictive dose of intravenous labetalol failure","Total dose of intravenous labetalol administered prior to meeting criteria for treatment failure.","From initiation of intravenous labetalol treatment until treatment failure or blood pressure control, assessed during hospitalization (up to 7 days)",{"measure":29,"description":30,"timeFrame":23},"Emergency cesarean delivery","Occurrence of emergency cesarean section during hospitalization.",null,{"allocation":31,"interventionModel":31,"interventionModelDescription":31,"primaryPurpose":31,"observationalModel":33,"timePerspective":34,"maskingInfo":31},"COHORT","PROSPECTIVE","Severe preeclampsia is a serious pregnancy complication associated with maternal and fetal morbidity and mortality, mainly due to insufficient blood pressure control. Intravenous labetalol is recommended as first-line treatment, but treatment failure is frequently observed in clinical practice, and its predictors are not well established.\n\nThe RELAPSE study is a prospective, multicenter observational study aiming to assess the association between predefined patient characteristics and failure of blood pressure control with intravenous labetalol monotherapy.\n\nData will be collected prospectively from routine clinical care and recorded in an electronic case report form. No additional procedures will be performed, and patient management will not be modified.\n\nApproximately 350 patients will be included across multiple centers. Participants will be followed from initiation of intravenous labetalol until hospital discharge (up to a maximum of 7 days).\n\nThe primary analysis will evaluate the association between treatment failure and predefined factors using multivariable logistic regression. Results will be expressed as odds ratios with 95% confidence intervals.\n\nThis study aims to improve the identification of patients at risk of treatment failure and contribute to better management of severe preeclampsia.","Adult pregnant women with severe preeclampsia requiring intravenous labetalol as part of routine clinical care.",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Agnès LE GOUEZ-DIVISIA","CONTACT","1 45 37 42 73","+33","agnes.le-gouez@aphp.fr",[45,59,69,81,94,106,117,129,141,152,163,176,186,196],{"facility":46,"status":31,"city":47,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"CHU Bordeaux","Bordeaux","France","FR",{"type":51,"coordinates":52},"Point",[53,54],-0.58046,44.84124,{"lat":54,"lon":53},[57],{"name":58,"role":40,"phone":31,"phoneExt":31,"email":31},"Aurélie SAN MIGUEL",{"facility":60,"status":31,"city":61,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Hôpital Antoine Béclère","Clamart",{"type":51,"coordinates":63},[64,65],2.26692,48.80299,{"lat":65,"lon":64},[68],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},{"facility":70,"status":31,"city":71,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"CHU Clermont-Ferrand","Clermont-Ferrand",{"type":51,"coordinates":73},[74,75],3.08682,45.77969,{"lat":75,"lon":74},[78],{"name":79,"role":40,"phone":31,"phoneExt":31,"email":80},"Martine BONNIN","mbonnin@chu-clermontferrand.fr",{"facility":82,"status":31,"city":83,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Hôpital Bicêtre","Le Kremlin-Bicêtre",{"type":51,"coordinates":85},[86,87],2.36073,48.81471,{"lat":87,"lon":86},[90],{"name":91,"role":40,"phone":92,"phoneExt":42,"email":93},"Marie BRUYERE","1 45 21 34 41","marie.bruyere@aphp.fr",{"facility":95,"status":31,"city":96,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"CHU Lille","Lille",{"type":51,"coordinates":98},[99,100],3.05512,50.63391,{"lat":100,"lon":99},[103],{"name":104,"role":40,"phone":31,"phoneExt":31,"email":105},"Max GONZALEZ-ESTEVEZ","max.gonzalezestevez@chu-lille.fr",{"facility":107,"status":31,"city":108,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"CHU Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant","Lyon",{"type":51,"coordinates":110},[111,112],4.84789,45.74906,{"lat":112,"lon":111},[115],{"name":116,"role":40,"phone":31,"phoneExt":31,"email":31},"Lionel BOUVET",{"facility":118,"status":31,"city":119,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"CHU Martinique","Martigues",{"type":51,"coordinates":121},[122,123],5.05526,43.40735,{"lat":123,"lon":122},[126],{"name":127,"role":40,"phone":31,"phoneExt":31,"email":128},"Thibaut RACKELBOOM","thibaut.rackelboom@chu-martinique.fr",{"facility":130,"status":31,"city":131,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"CHRU Nancy","Nancy",{"type":51,"coordinates":133},[134,135],6.18496,48.68439,{"lat":135,"lon":134},[138],{"name":139,"role":40,"phone":31,"phoneExt":31,"email":140},"Florence VIAL","F.VIAL@chru-nancy.fr",{"facility":142,"status":31,"city":143,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"CH Agen-Nerac","Nérac",{"type":51,"coordinates":145},[146,147],0.33844,44.13597,{"lat":147,"lon":146},[150],{"name":151,"role":40,"phone":31,"phoneExt":31,"email":31},"Sandrine PAQUIN",{"facility":153,"status":31,"city":154,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"CHU Carémeau","Nîmes",{"type":51,"coordinates":156},[157,158],4.35788,43.83665,{"lat":158,"lon":157},[161],{"name":162,"role":40,"phone":31,"phoneExt":31,"email":31},"Estelle MORAU",{"facility":164,"status":31,"city":165,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Hôpital Armand-Trousseau","Paris",{"type":51,"coordinates":167},[168,169],2.3488,48.85341,{"lat":169,"lon":168},[172],{"name":173,"role":40,"phone":174,"phoneExt":42,"email":175},"Marie-Pierre BONNET","1 44 73 61 99","marie-pierre.bonnet@aphp.fr",{"facility":177,"status":31,"city":165,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":178,"geoPoint":180,"contacts":181},"Hôpital Cochin Port Royal",{"type":51,"coordinates":179},[168,169],{"lat":169,"lon":168},[182],{"name":183,"role":40,"phone":184,"phoneExt":42,"email":185},"Catherine FISCHER","1 58 41 41 41","catherine.fischer2@aphp.fr",{"facility":187,"status":31,"city":165,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":188,"geoPoint":190,"contacts":191},"Hôpital Necker",{"type":51,"coordinates":189},[168,169],{"lat":169,"lon":168},[192],{"name":193,"role":40,"phone":194,"phoneExt":42,"email":195},"Hawa KEITA-MEYER","1 44 49 41 72","hawa.keita@aphp.fr",{"facility":197,"status":31,"city":198,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"CH de Roubaix","Roubaix",{"type":51,"coordinates":200},[201,202],3.17456,50.69421,{"lat":202,"lon":201},[205],{"name":206,"role":40,"phone":31,"phoneExt":31,"email":207},"Anne-Sophie BAPTISTE","anne-sophie.baptiste@ch-roubaix.fr",{"type":209,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100635004",false,"NCT07547046","Factors Associated With Blood Pressure Control Failure to Intravenous Labetalol in Severe Preeclampsia","Assessment of the Association Between Predefined Factors and Response or Failure of Blood Pressure Control With Intravenous Labetalol Monotherapy in Severe Preeclampsia: a Multicenter Observational Study","RELAPSE","Inclusion Criteria:\n\n* Adult patient (age ≥ 18 years)\n* Pregnancy ≥ 24 weeks of gestation with one or more viable fetuses and severe preeclampsia requiring intravenous labetalol administration, either as continuous infusion (IVSE) or intravenous bolus titration\n\nExclusion Criteria:\n\n* Contraindication to labetalol (asthma, chronic obstructive pulmonary disease, bradycardia, current or history of intracardiac conduction disorders, or history of hypersensitivity reaction)\n* Intravenous antihypertensive treatment initiated prior to inclusion\n* Patient refusal or objection to the use of her healthcare data for research purposes","FEMALE","18 Years",{"count":220,"type":221},350,"ESTIMATED","OBSERVATIONAL","Severe preeclampsia is a serious pregnancy complication that can lead to severe maternal and fetal outcomes, particularly when blood pressure is not adequately controlled. In France, intravenous labetalol is recommended as the first-line treatment for severe hypertension in preeclampsia. However, in clinical practice, failure to control blood pressure with labetalol is frequently observed, and the factors associated with this lack of response remain poorly understood.\n\nThe RELAPSE study is a prospective, multicenter observational study designed to identify factors associated with failure of blood pressure control with intravenous labetalol monotherapy in patients with severe preeclampsia.\n\nThe main hypothesis is that certain patient characteristics, such as maternal clinical profile, obstetric history, or biological parameters, may be associated with a higher risk of treatment failure. Identifying these factors could help clinicians better anticipate inadequate response to labetalol and adapt treatment strategies more rapidly.\n\nData will be collected from routine clinical care without modifying patient management. Patients will be followed from the initiation of intravenous labetalol until hospital discharge. The study will include approximately 350 patients across multiple centers.\n\nBy improving the understanding of predictors of treatment failure, this study aims to contribute to better management of severe preeclampsia and to reduce maternal and neonatal complications.",[225],"Severe Preeclampsia",[227,228,229,230,231,232],"Severe preeclampsia","hypertensive disorders of pregnancy","pregnancy-related hypertension","maternal morbidity","antihypertensive treatment fa","intravenous labetalol; blood pressure control","NOT_YET_RECRUITING","2026-04-20",{"date":236,"type":237},"2026-04-23","ACTUAL",{"date":239,"type":221},"2026-04-01",{"date":241,"type":221},"2026-05-07",{"name":5,"class":6},14]