[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550124":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":55,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":25,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":25,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"CHU de Reims","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Magnesium Sulfate","EXPERIMENTAL","Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space",[13],"Drug: Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space",{"label":15,"type":16,"description":17,"interventionNames":18},"Isotonic saline","PLACEBO_COMPARATOR","Injection of Isotonic saline + 2 mg morphine into the epidural space",[19],"Drug: Injection of Isotonic saline + 2 mg morphine into the epidural space",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","When the patient agrees to enter the protocol, the investigators randomize the patient and proceed to the injection of morphine 2 mg into the epidural catheter + magnesium sulfate 500 mg",[9],null,{"type":22,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"When the patient agrees to enter the protocol, the investigators randomize the patient and proceed to Injection of morphine 2 mg into the epidural catheter + isotonic saline. This is the protocol the investigators use in daily practice for parturients who have undergone Caesarean section, in line with the French recommendations of anesthesia societies",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Maxime Riffault","CONTACT","00336 79 63 29 55","mriffault@chu-reims.fr",[36],{"facility":37,"status":38,"city":39,"state":25,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Chu Reims","RECRUITING","Reims","51092","France","FR",{"type":44,"coordinates":45},"Point",[46,47],4.02853,49.26526,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":53,"email":54},"Damien JOLLY","326788472","33","djolly@chu-reims.fr",{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100550124","phase-4-evaluation-of-the-efficacy-of-the-addition-of-magnesium-sulfate-to-morphine-on-the-occurrence-of-acute-urinary-retention-following-epidural-anesthesia-for-cesarean-section-100550124",false,"NCT06442995","Evaluation of the Efficacy of the Addition of Magnesium Sulfate to Morphine on the Occurrence of Acute Urinary Retention Following Epidural Anesthesia for Cesarean Section.","Superiority Randomized Double-blind Controlled Trial of Epidural Magnesium Sulfate Addition Versus Placebo on the Occurrence of Acute Post-caesarean Urinary Retention","EPIMAG","Inclusion Criteria:\n\n* Patients who have undergone scheduled or emergency Caesarean section surgery under extended epidural anesthesia or combined epidural and spinal anesthesia at the Reims University Hospital.\n* Patients who have just undergone caesarean section and have the epidural catheter in place in the post-interventional monitoring room (SSPI).\n* Patients who agree to take part in the research and have signed the informed consent form\n* Patients of legal age\n* Patients affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Minor patients\n* Patients protected by law\n* Patients allergic to local anesthetics, morphine or magnesium sulfate\n* Patients with severe renal insufficiency (GFR \\\u003C 30 ml\u002Fmin)\n* Patients with pre-pregnancy mictional disorders\n* Patients with an American Society of Anesthesiologists (ASA) score of 4\n* Patients undergoing caesarean section under general anaesthesia, after failure of perimedullary anaesthesia\n* Patients with accidental intraoperative injury to the urinary tract\n* Patients who have received intravenous magnesium sulfate in the 24 hours preceding cesarean section","FEMALE","18 Years",{"count":68,"type":69},290,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","Peri-medullary anesthesia is the preferred anesthetic technique for Caesarean surgery. Compared with general anesthesia, it reduces maternal and fetal morbidity and mortality, as well as postoperative pain. However, this technique exposes the patient to the adverse effects of peri-medullary morphine, particularly the risk of postoperative urinary retention. Urinary retention during the first 72 hours after Caesarean section affects around 33% of parturients.\n\nThis is a particularly debilitating event for parturients, exposing them to the risk of further urinary catheterization, increased theoretical risk of urinary tract infection, traumatic urethral injury, hindered accelerated rehabilitation and altered maternal satisfaction.\n\nSeveral studies have demonstrated the benefits of adding magnesium sulfate to epidural anesthesia for Caesarean sections, notably by reducing postoperative pain.\n\nMagnesium sulfate may also have a facilitating effect on postoperative micturition, thanks to its sympathicolytic effect.\n\nThis hypothesis is supported by a retrospective study carried out in our maternity hospital, which showed a 15% reduction in post-Caesarean urinary retention when women were given magnesium sulfate in addition to the drugs traditionally used for epidurals.\n\nThis little-known property needs to be clarified",[75],"Urinary Retention","2025-12-22",{"date":78,"type":79},"2025-12-30","ACTUAL",{"date":81,"type":79},"2025-01-16",{"date":83,"type":69},"2027-12",{"name":5,"class":6},1]