[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653207":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":38,"studyPopulation":26,"armGroups":39,"interventions":51,"overallOfficials":26,"centralContacts":59,"locations":65,"responsibleParty":81,"collaborators":26,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":26,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":26,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":113,"whyStopped":26,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Khyber Girls Medical College","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Systolic Blood Pressure (SBP) from Baseline","Change in systolic blood pressure from baseline (mean of three pre-anaesthesia readings) measured at 2, 5, and 10 minutes after oxytocin administration.","Baseline; 2 minutes, 5 minutes, and 10 minutes after oxytocin administration",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Change in Diastolic Blood Pressure and Heart Rate from Baseline","Change in diastolic blood pressure and heart rate from baseline at defined time points after oxytocin administration.","1, 2, 3, 5, 10, 15, and 20 minutes after oxytocin administration",{"measure":19,"description":20,"timeFrame":21},"Incidence of Clinically Significant Hypotension","Proportion of participants who develop systolic blood pressure \\\u003C 90 mmHg or a fall of \\> 20% from baseline after oxytocin administration.","Within 20 minutes after oxytocin administration",{"measure":23,"description":24,"timeFrame":25},"Uterine Contraction Scale Score","Uterine tone assessed by the operating obstetrician using a 5-point scale (Grade 1 = atonic to Grade 5 = very well contracted) at 5 minutes after placental delivery. Grade 1 or 2 is classified as uterine atony.","5 minutes after placental delivery",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"RANDOMIZED","PARALLEL","Two-group parallel randomised controlled trial comparing oxytocin bolus versus slow infusion.","TREATMENT",{"masking":33,"maskingDescription":34,"whoMasked":35},"DOUBLE","Participants and the data collector (outcomes assessor) are blinded to group allocation. The anaesthetist administering the study drug cannot be blinded due to the different administration techniques (bolus versus infusion), but is not involved in data recording.",[36,37],"PARTICIPANT","OUTCOMES_ASSESSOR","Postpartum haemorrhage remains a leading cause of maternal mortality worldwide. Oxytocin is the first-line uterotonic agent used after delivery of the baby during caesarean section. When given as a rapid intravenous bolus, oxytocin can cause significant hypotension, tachycardia and other haemodynamic changes, especially in women under spinal anaesthesia.\n\nThis prospective, randomised, controlled trial will compare the haemodynamic effects of oxytocin 5 IU administered as a rapid intravenous bolus versus the same dose given as a slow intravenous infusion over 15 minutes in women undergoing elective caesarean section under spinal anaesthesia.\n\nSixty women aged 18-40 years with singleton pregnancy at 37-42 weeks, ASA physical status I or II, will be randomly allocated to one of two groups:\n\nGroup A (Bolus): Oxytocin 5 IU given as an intravenous bolus over 15 seconds immediately after umbilical cord clamping.\n\nGroup B (Infusion): Oxytocin 5 IU diluted and infused over 15 minutes via syringe pump immediately after umbilical cord clamping.\n\nThe primary outcome is the change in systolic blood pressure from baseline at 2, 5 and 10 minutes after oxytocin administration. Secondary outcomes include changes in diastolic blood pressure and heart rate, incidence of hypotension and tachycardia, vasopressor requirements, uterine tone assessed by a 5-point scale, estimated blood loss, and side effects such as nausea, vomiting, flushing and chest discomfort.\n\nThe study will be conducted at Hayatabad Medical Complex, Peshawar. All participants will receive standard spinal anaesthesia and routine care. The results are expected to provide local evidence to support safer oxytocin administration practices during caesarean section under spinal anaesthesia.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Bolus Group","ACTIVE_COMPARATOR","Participants will receive oxytocin 5 IU in 1 mL normal saline as an intravenous bolus over 15 seconds immediately after umbilical cord clamping, followed by 9 mL normal saline infusion over 15 minutes (to maintain blinding).",[45],"Drug: Oxytocin",{"label":47,"type":48,"description":49,"interventionNames":50},"Infusion Group","EXPERIMENTAL","Participants will receive oxytocin 5 IU diluted in 50 mL normal saline administered via syringe pump over 15 minutes immediately after umbilical cord clamping. A simultaneous 1 mL normal saline bolus will be given over 15 seconds to maintain blinding of the initial injection.",[45],[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"DRUG","Oxytocin","Oxytocin 5 IU administered either as a rapid intravenous bolus over 15 seconds or as a slow intravenous infusion over 15 minutes immediately after umbilical cord clamping during elective caesarean section under spinal anaesthesia.",[41,47],[58],"Syntocinon",[60],{"name":61,"role":62,"phone":63,"phoneExt":26,"email":64},"Fareeha Zahir, MBBS \u002F FCPS-II Trainee","CONTACT","+923319932275","fareehak933@gmail.com",[66],{"facility":67,"status":26,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Hayatabad Medical Complex \u002F Khyber Girls Medical College","Peshawar","Khyber Pakhtunkhwa","25000","Pakistan","PK",{"type":74,"coordinates":75},"Point",[76,77],71.57849,34.008,{"lat":77,"lon":76},[80],{"name":61,"role":62,"phone":63,"phoneExt":26,"email":64},{"type":82,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100653207","effect-of-oxytocin-bolus-versus-slow-infusion-on-haemodynamic-stability-during-caesarean-section-under-spinal-anaesthesia-100653207",false,"NCT07784478","Effect of Oxytocin Bolus Versus Slow Infusion on Haemodynamic Stability During Caesarean Section Under Spinal Anaesthesia","Effect of Oxytocin Administration Technique on Haemodynamic Stability During Caesarean Section Under Spinal Anaesthesia: A Randomised Controlled Trial","Inclusion Criteria:\n\n* Adult female patients aged 18 to 40 years\n* American Society of Anesthesiologists (ASA) physical status class I or II\n* Singleton pregnancy at 37 to 42 weeks gestational age\n* Scheduled for elective caesarean section under spinal anaesthesia\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Patients with anticipated hemodynamic instability including severe preeclampsia\u002Feclampsia, placenta previa with active bleeding, placental abruption, or hemorrhagic shock\n* Pre-existing cardiovascular disease including ischemic heart disease, valvular heart disease, cardiomyopathy, or arrhythmias\n* Baseline systolic blood pressure \\\u003C 100 mmHg or heart rate \\> 100 bpm before spinal block\n* Known hypersensitivity to oxytocin\n* Failed spinal anaesthesia requiring conversion to general anaesthesia\n* Patients receiving medications that may alter the hemodynamic response to oxytocin (beta-blockers, calcium channel blockers, ACE inhibitors, or angiotensin receptor blockers)\n* Pre-existing anaemia (Hb \\\u003C 8 g\u002FdL)","FEMALE","18 Years","40 Years",{"count":94,"type":95},60,"ESTIMATED","INTERVENTIONAL",[98],"NA","This study compares two standard ways of giving oxytocin (a medicine that helps the uterus contract) after the baby is born during a planned caesarean section performed under spinal anaesthesia. One group of women will receive oxytocin as a quick injection into the vein. The other group will receive the same dose of oxytocin as a slow infusion over 15 minutes. The researchers want to find out which method causes less drop in blood pressure and other heart-related changes, while still providing good contraction of the uterus and preventing excessive bleeding.",[101,102,103,104],"Cesarean Section","Hypotension","Postpartum Hemorrhage","Spinal Anesthesia",[54,106,107,108,109,110,111,112],"Bolus","Infusion","Haemodynamic stability","Elective caesarean section","Spinal anaesthesia","Uterine tone","Vasopressor","NOT_YET_RECRUITING","2026-08-20",{"date":116,"type":117},"2026-08-25","ACTUAL",{"date":119,"type":95},"2026-09-01",{"date":121,"type":95},"2027-04-01",{"name":5,"class":6},1]