[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577413":3},{"organization":4,"outcomesModule":7,"designInfo":122,"detailedDescription":134,"studyPopulation":125,"armGroups":135,"interventions":146,"overallOfficials":125,"centralContacts":156,"locations":166,"responsibleParty":296,"collaborators":125,"id":300,"slug":301,"hasResults":302,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":302,"sex":308,"minAge":309,"maxAge":125,"enrollmentInfo":310,"targetDuration":125,"studyType":313,"phases":314,"briefSummary":316,"conditions":317,"keywords":320,"overallStatus":169,"whyStopped":125,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":337},{"fullName":5,"class":6},"Zealand University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":35},[9,13],{"measure":10,"description":11,"timeFrame":12},"Level of pain when mobilising from supine to sitting position within 24 hours","Longitudinal measurements of NRS (0-10) at 6, 12, 18 and 24 hours with most focus on the 24-hour pain level","6, 12, 18 and 24 hours following spinal anaesthesia",{"measure":14,"description":15,"timeFrame":16},"Maternal and neonatal serious adverse events","Binary composite outcome:\n\n1. Death of either participant or neonate within 7 days\n2. Participants with clinically significant respiratory depression within 24 hours, defined as respiratory depression documented in the electronic medical record, e.g. need for airway management or pharmacological intervention (subjective assessment by treating clinician, validated by 2 investigators)\n3. Neonates needing admission to neonatal intensive care unit within 48 hours\n4. Hospitalisation of either participant or neonate within 7 days after discharge\n5. Participants with severe vomiting or nausea within 24 hours, defined as ≥5 points on the 'Simplified postoperative nausea and vomiting impact scale'63 at any time point (6, 12, 18 and 24 hours)","Within 7 days from discharge",[18,22,25,28,31],{"measure":19,"description":20,"timeFrame":21},"Opioid consumption within 24 hours","Mg oral morphine equivalents","Within 24 hours following spinal anaesthesia",{"measure":23,"description":24,"timeFrame":21},"Morphine associated adverse effects within 24 hours","Binary composite outcome: participants experiencing either:\n\n1. Vomiting (patient reported, yes\u002Fno)\n2. Nausea\n3. Dizziness\n4. Pruritus Nausea, dizziness, and pruritus is assessed as \"none\", \"little\", \"moderate\", or \"severe\" with patients reporting \"moderate\" or \"severe\" categorised as having a positive outcome\n5. Urinary retention, defined as need for re-catheterisation within 24 hours",{"measure":26,"description":27,"timeFrame":21},"Obstetric quality of recovery score at 24 hours","Obs-QoR-10 (0-100)",{"measure":29,"description":30,"timeFrame":21},"Participants satisfaction with postoperative pain-treatment during the first 24 hours","NRS 0-10",{"measure":32,"description":33,"timeFrame":34},"Established breastfeeding at 30 days","Proportion of neonates being exclusively breastfed at 30 days","30 days from surgery",[36,39,41,44,47,51,54,57,59,63,67,69,71,73,75,77,79,81,83,85,87,90,94,97,100,103,107,110,114,118],{"measure":37,"description":38,"timeFrame":16},"Serious adverse events, pain at 24 hours and opioid consumption, compared using Win Ratio","A composite outcome analysed using Win Ratio, consisting of\n\n1. Maternal and neonatal serious adverse events (as defined in the primary outcome)\n2. Level of pain when mobilising from supine to sitting position at 24 hours (NRS 0-10)\n3. Opioid consumption within 24 hours (mg oral morphine equivalents)",{"measure":40,"description":30,"timeFrame":21},"Overall severity of pruritus within 24 hours",{"measure":42,"description":43,"timeFrame":21},"Pharmacological treatment for opioid-related adverse effects within 24 hours","Dexametasone, dosage (mg) 5-HT3 receptor antagonists, type, dosage (mg) Dopamine receptor antagonists, type, dosage (mg) Droperidol, dosage (mg) Antihistamines, type, dosage (mg) Pethidine, dosage (mg) Naloxone, dosage (mg) Clonidine, dosage (mg)",{"measure":45,"description":46,"timeFrame":12},"Ability to mobilise independently","Proportion of participants able to mobilise independently at 6, 12, 18 and 24 hours",{"measure":48,"description":49,"timeFrame":50},"Level of pain at rest within 48 hours","Longitudinal measurements of NRS (0-10) at 6, 12, 18, 24 and 48 hours","6, 12, 18, 24 and 48 hours following spinal anaesthesia",{"measure":52,"description":20,"timeFrame":53},"Opioid consumption within 48 hours","Within 48 hours following spinal anaesthesia",{"measure":55,"description":56,"timeFrame":21},"\"Rescue\" supplemental pain treatment with truncal nerve block or epidural within 24 hours","Binary composite outcome: participants receiving either an unplanned postoperative truncal nerve block or epidural analgesia within 24 hours",{"measure":58,"description":30,"timeFrame":53},"Level of pain when mobilising from supine to sitting position at 48 hours",{"measure":60,"description":61,"timeFrame":62},"Total consumption of non-opioid analgesic medication (paracetamol, NSAIDs) within 24 hours and 48 hours","Paracetamol, dosage (mg) NSAIDs, type, dosage (mg)","Within 24 and 48 hours following spinal anaesthesia",{"measure":64,"description":65,"timeFrame":66},"Intraoperative nausea, vomiting and pruritus","Binary composite outcome: participants experiencing either\n\n1. Intraoperative nausea\n2. Intraoperative vomiting\n3. Intraoperative pruritus Nausea and pruritus are assessed as \"none\", \"little\", \"moderate\", or \"severe\" with patients reporting \"moderate\" or \"severe\" categorised as having a positive outcome. Vomiting is assessed as yes\u002Fno.\n\nIntraoperative is defined as from administration of spinal anaesthesia until the patient is leaving the operating room","During surgery",{"measure":68,"description":30,"timeFrame":21},"Overall severity of pain within 24 hours (ObsQoR-10)",{"measure":70,"description":30,"timeFrame":21},"Overall severity of nausea\u002Fvomiting within 24 hours (ObsQoR-10)",{"measure":72,"description":30,"timeFrame":21},"Overall severity of dizziness within 24 hours (ObsQoR-10)",{"measure":74,"description":30,"timeFrame":21},"Overall severity of shivering within 24 hours (ObsQoR-10)",{"measure":76,"description":30,"timeFrame":21},"Overall feeling of being comfortable within 24 hours (ObsQoR-10)",{"measure":78,"description":30,"timeFrame":21},"Overall ability to mobilise independently within 24 hours (ObsQoR-10)",{"measure":80,"description":30,"timeFrame":21},"Overall ability to independently hold infant within 24 hours (ObsQoR-10)",{"measure":82,"description":30,"timeFrame":21},"Overall ability to nurse\u002Ffeed infant independently within 24 hours (ObsQoR-10)",{"measure":84,"description":30,"timeFrame":21},"Overall ability to handle personal hygiene within 24 hours (ObsQoR-10)",{"measure":86,"description":30,"timeFrame":21},"Overall feeling of being in control within 24 hours (ObsQoR-10)",{"measure":88,"description":89,"timeFrame":16},"Length of hospital stay","Total length of primary hospital stay (hours)",{"measure":91,"description":92,"timeFrame":93},"Readmission or unplanned hospital re-attendance within 7 days","Binary composite outcome: participants needing either:\n\n1. Hospital readmission within 7 days\n2. Re-attendance (unplanned hospital out-patient consultation) within 7 days","Within 7 days following surgery",{"measure":95,"description":96,"timeFrame":21},"Failed or insufficient spinal anaesthesia","Binary composite outcome: participants needing either:\n\n1. Conversion to general anaesthesia\n2. Repeated neuraxial procedure\n3. Supplemental intraoperative pain treatment",{"measure":98,"description":99,"timeFrame":93},"Hospital-free days within 7 days","Number of days out of hospital for both participant and neonate within 7 days",{"measure":101,"description":102,"timeFrame":93},"Ogilvie's syndrome\u002Fileus within 7 days","Proportion of participants with Ogilvie's syndrome\u002Fileus that requires surgery or treatment with neostigmine within 7 days",{"measure":104,"description":105,"timeFrame":106},"Apgar score at 5 minutes following birth","0-10","5 minutes following birth",{"measure":108,"description":109,"timeFrame":106},"Apgar score \u003C7 at 5 minutes following birth","Proportion of neonates with Apgar score \\\u003C7 at 5 minutes following birth",{"measure":111,"description":112,"timeFrame":113},"Neonatal need for respiratory support within 48 hours","Proportion of neonates needing respiratory support within 48 hours, defined as either:\n\n1. Continuous positive airway pressure treatment\n2. Positive pressure ventilation\n3. HNF (high nasal flow)\n4. Intubation\n5. Oxygen therapy","Within 48 hours following birth",{"measure":115,"description":116,"timeFrame":117},"Neonatal sedation resulting in failed breast-\u002Fbottle feeding within 48 hours","Proportion of neonates not being breastfed or bottle fed due to neonatal sedation, corresponding to L=0 (too sleepy or reluctant, no sustained latch or suck achieved) on the LATCH scoring system","24 and 48 hours following birth",{"measure":119,"description":120,"timeFrame":121},"Neonatal hospitalisation within 24 hours after discharge","Proportion of neonates hospitalised within 24 hours after discharge of participant","24 hours after discharge",{"allocation":123,"interventionModel":124,"interventionModelDescription":125,"primaryPurpose":126,"observationalModel":125,"timePerspective":125,"maskingInfo":127},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":128,"maskingDescription":125,"whoMasked":129},"QUADRUPLE",[130,131,132,133],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","BACKGROUND AND OBJECTIVE:\n\nCaesarean section is surgical procedure associated with moderate to severe postoperative pain, which can negatively affect recovery, mother-child bonding and the initiation of breastfeeding. Intrathecal morphine may offer pain relief for up to 24 hours, and is widely implemented and recommended as part of multimodal postoperative pain management. Despite the widespread use, there is limited evidence for the balance between benefits and harms of low-dose intrathecal morphine in patients undergoing caesarean section.\n\nThe objective of the trial is to evaluate analgesic efficacy as well as maternal and neonatal safety associated with addition of low-dose (80 µg) intrathecal morphine versus placebo to standard multimodal postoperative pain management in patients undergoing planned caesarean section.\n\nThe trial is a superiority, investigator-initiated, pragmatic, randomised, blinded, placebo-controlled multicentre trial.\n\nTRIAL SIZE: A total of 1,312 participants is required to show\u002Freject a 35% relative increase in the composite co-primary safety outcome, with an estimated baseline incidence of 21% without intrathecal morphine and a power of 80%. We adjust statistically for having two primary outcomes by using an alpha of 2.5%. We reach a power of 99.9% for the co-primary outcome of pain score with an estimated mean Numeric Rating Scale (0-10) of 4.88, standard deviation of 2.0 and relevant mean difference of 1.0.\n\nETHICAL CONSIDERATIONS: Intrathecal morphine for caesarean delivery represents a common medical practice which is not supported by robust evidence. High-quality data on efficacy and safety of the treatment will enable clinicians to tailor postoperative pain treatment to each patient, thus improving care for future patients. Choosing low-dose morphine minimises the risk of adverse effects, and all trial participants will receive standard multimodal pain treatment. There is no evidence of any harmful neonatal effects. All trial participants will give informed consent, and the trial will adhere to the Declaration of Helsinki as well as national and international standards of good clinical practice.\n\nPLANNED SUBSTUDIES:\n\n* Incidence of desaturation and bradypnea during the first 24 hours following surgery, assessed using continuous wireless respiratory monitoring in a subpopulation of 100 patients at 3 trial sites.\n* Efficacy and safety of intrathecal morphine in participant subgroups: The influence of different pre-existing factors on the primary outcomes",[136,141],{"label":137,"type":138,"description":125,"interventionNames":139},"Intrathecal morphine","EXPERIMENTAL",[140],"Drug: Intrathecal Morphine",{"label":142,"type":143,"description":125,"interventionNames":144},"Placebo","PLACEBO_COMPARATOR",[145],"Drug: Placebo (Sodium Chloride Injection, 0.9%)",[147,152],{"type":148,"name":149,"description":150,"armGroupLabels":151,"otherNames":125},"DRUG","Intrathecal Morphine","80 μg preservative-free morphine (0.2 ml) added to a single-shot spinal anaesthesia consisting of 11.5 mg hyperbaric bupivacaine and 10 μg fentanyl",[137],{"type":148,"name":153,"description":154,"armGroupLabels":155,"otherNames":125},"Placebo (Sodium Chloride Injection, 0.9%)","0.2 ml of isotonic sodium chloride added to a single-shot spinal anaesthesia consisting of 11.5 mg hyperbaric bupivacaine and 10 μg fentanyl.",[142],[157,162],{"name":158,"role":159,"phone":160,"phoneExt":125,"email":161},"Anneline B Seegert, MD","CONTACT","+4547326397","ansee@regionsjaelland.dk",{"name":163,"role":159,"phone":164,"phoneExt":125,"email":165},"Anne J Wikkelsø, MD, PhD","+4547325046","awik@regionsjaelland.dk",[167,185,202,216,230,244,258,272,286],{"facility":168,"status":169,"city":170,"state":125,"zip":171,"country":172,"countryCode":173,"cosmosGeoPoint":174,"geoPoint":179,"contacts":180},"Aarhus University Hospital","RECRUITING","Aarhus","8200","Denmark","DK",{"type":175,"coordinates":176},"Point",[177,178],10.21076,56.15674,{"lat":178,"lon":177},[181],{"name":182,"role":159,"phone":183,"phoneExt":125,"email":184},"Deepti Jain, MD","+4530911052","deepjain@rm.dk",{"facility":186,"status":169,"city":187,"state":125,"zip":188,"country":172,"countryCode":173,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Copenhagen University Hospital - Rigshospitalet","Copenhagen","2100",{"type":175,"coordinates":190},[191,192],12.56553,55.67594,{"lat":192,"lon":191},[195,199],{"name":196,"role":159,"phone":197,"phoneExt":125,"email":198},"Kim Ekelund, MD, PhD","+4535450563","kim.ekelund@regionh.dk",{"name":200,"role":159,"phone":125,"phoneExt":125,"email":201},"Kim Lindelof, MD, PhD","kim.lindelof@regionh.dk",{"facility":203,"status":169,"city":204,"state":125,"zip":205,"country":172,"countryCode":173,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Copenhagen University Hospital - Herlev and Gentofte, Herlev","Herlev","2730",{"type":175,"coordinates":207},[208,209],12.43998,55.72366,{"lat":209,"lon":208},[212],{"name":213,"role":159,"phone":214,"phoneExt":125,"email":215},"Kim Wildgaard, MD, PhD","+4538682170","Kim.Wildgaard@regionh.dk",{"facility":217,"status":169,"city":218,"state":125,"zip":219,"country":172,"countryCode":173,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Copenhagen University Hospital - North Zealand, Hillerød","Hillerød","3400",{"type":175,"coordinates":221},[222,223],12.30081,55.92791,{"lat":223,"lon":222},[226],{"name":227,"role":159,"phone":228,"phoneExt":125,"email":229},"Patricia Duch, MD","+4548292504","patricia.duch@regionh.dk",{"facility":231,"status":169,"city":232,"state":125,"zip":233,"country":172,"countryCode":173,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Regional Hospital Horsens","Horsens","8700",{"type":175,"coordinates":235},[236,237],9.85034,55.86066,{"lat":237,"lon":236},[240],{"name":241,"role":159,"phone":242,"phoneExt":125,"email":243},"Ulrick Skipper Espelund, Associate Professor, PhD","+4561671090","ulrick.espelund@rm.dk",{"facility":245,"status":169,"city":246,"state":125,"zip":247,"country":172,"countryCode":173,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"Copenhagen University Hospital - Amager and Hvidovre, Hvidovre","Hvidovre","2650",{"type":175,"coordinates":249},[250,251],12.47708,55.64297,{"lat":251,"lon":250},[254],{"name":255,"role":159,"phone":256,"phoneExt":125,"email":257},"Maria E Kromann, MD, PhD","+4538620694","Maria.Egede.Kromann@regionh.dk",{"facility":259,"status":169,"city":260,"state":125,"zip":261,"country":172,"countryCode":173,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"University Hospital of Southern Denmark - Lillebælt Hospital, Kolding","Kolding","6000",{"type":175,"coordinates":263},[264,265],9.47216,55.4904,{"lat":265,"lon":264},[268],{"name":269,"role":159,"phone":270,"phoneExt":125,"email":271},"Helene K Nedergaard, MD, PhD","+4553272244","helene.korvenius.nedergaard@rsyd.dk",{"facility":273,"status":169,"city":274,"state":125,"zip":275,"country":172,"countryCode":173,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"University Hospital of Southern Denmark - Odense University Hospital","Odense C","5000",{"type":175,"coordinates":277},[278,279],10.39538,55.40841,{"lat":279,"lon":278},[282],{"name":283,"role":159,"phone":284,"phoneExt":125,"email":285},"Mette L Andersson","+4565414937","mf_andersson@me.com",{"facility":5,"status":169,"city":287,"state":125,"zip":288,"country":172,"countryCode":173,"cosmosGeoPoint":289,"geoPoint":293,"contacts":294},"Roskilde","4000",{"type":175,"coordinates":290},[291,292],12.08035,55.64152,{"lat":292,"lon":291},[295],{"name":163,"role":159,"phone":164,"phoneExt":125,"email":165},{"type":297,"investigatorFullName":298,"investigatorTitle":299,"investigatorAffiliation":5,"oldNameTitle":125,"oldOrganization":125},"SPONSOR_INVESTIGATOR","Anne Juul Wikkelsø","Associate Professor, Senior Consultant, PhD","100577413","phase-4-efficacy-and-safety-of-intrathecal-morphine-for-postoperative-pain-management-following-planned-caesarean-section-100577413",false,"NCT06797973","Efficacy and Safety of Intrathecal Morphine for Postoperative Pain Management Following Planned Caesarean Section","MOTHER Trial: Efficacy and Safety of Low-dose Intrathecal Morphine Following Planned Caesarean Section - a Randomised, Blinded, Clinical, Controlled, Multicentre Trial.","MOTHER","Inclusion Criteria:\n\n* Patients ≥ 18 years\n* Singleton pregnancy\n* Scheduled for planned caesarean section performed under spinal anaesthesia\n* Written informed consent\n\nExclusion Criteria:\n\n* Allergy to or contraindications towards trial medication\n* Patients planned for postoperative epidural due to expected difficult postoperative pain management\n* Patients planned for combined spinal-epidural as primary anaesthesia\n* Inability to understand and read Danish\n* Previous inclusion in the trial","FEMALE","18 Years",{"count":311,"type":312},1312,"ESTIMATED","INTERVENTIONAL",[315],"PHASE4","The goal of this clinical trial is to learn if morphine added to the spinal anaesthesia can improve postoperative pain treatment for patients undergoing caesarean section, without increasing the risk of serious adverse events in mother and baby.\n\nThe main questions it aims to answer are:\n\n* Is the treatment effective in preventing postoperative pain?\n* Is the treatment safe for both mother and baby?\n\nParticipants will be given a normal spinal anaesthesia with addition of either morphine or sodium chloride (inactive substance). All participants will receive standard postoperative pain treatment, including morphine tablets as needed. Researchers will collect data from the electronic medical record and ask the participants to fill out questionnaires about pain levels and possible side effects.",[318,319],"Caesarean Section","Postoperative Pain",[321,322,323,324,325,137,326,327],"Caesarean section","Cesarean section","Cesarean delivery","Caesarean delivery","Postoperative pain","Spinal morphine","elective caesarean","2026-09-10",{"date":330,"type":331},"2026-09-11","ACTUAL",{"date":333,"type":331},"2025-07-15",{"date":335,"type":312},"2027-06-30",{"name":298,"class":6},9]