Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Clinical Trials Registry - India
Year
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2023
INTERVENTION: Intervention1: Carbetocin: Carbetocin 100 mcg single i.v. bolus would be given over 1 minute on delivery of the foetus and the clamping of the umbilical cord. Control Intervention1: Oxytocin: Oxytocin 20IU in 1000ml NaCl(0.9%) @ 150ml/hr would be given after the delivery of the foetus and clamping of the umbilical cord. CONDITION: PRIMARY OUTCOME: To assess the efficacy of Oxytocin and Carbetocin in terms of intraoperative blood loss, additional uterotonic needed and adverse effects if any in caesarean delivery with high risk of post‐partum haemorrhage. To compare the hemodynamic effects of Oxytocin and Carbetocin (effects on heart rate and blood pressure) ; Timepoint: Heart rate and blood pressure noted before skin incision, after 1 minute, 3 minutes, 5 minutes, at the time of skin closure, after 2 hours, after 12 hours. Uterine tone noted at time of delivery and after 3 minutes, 6 minutes, 9 minutes, 12 minutes, 2 hours, 12 hours. ; SECONDARY OUTCOME: 1)Demographic data ; 2)Uterine tone ; 3)Additional uterotonic used ; 4)Additional side effectsTimepoint: 1)Maternal Age(years) and Gestational Age(weeks) ; 2)Likert Scale at time of delivery, after 3 minutes, after 6 minutes, after 9 minutes, after 12 minutes after 2 hours, after 12 hours(Likert scale 0‐4, 0‐floppy,1‐soft, 2‐poorly contracted, 3‐well contracted, 4‐hard rock) ; 3)Additional uterotonics used ; 4)Nausea, Vomitting, Flushing, Tachycardia, Hypotension, Headache, Chestpain ; INCLUSION CRITERIA: High risk pregnant patients posted for elective cesarean delivery under spinal anaesthesia of ASA Grade III and IV with 35‐40 weeks of gestation, Multiple pregnancies, Previous cesarean scar, Presence of uterine fibroids, Previous myomectomy, Presence of placenta previa, Past history of PPH
Epistemonikos ID: b13f5f06b1597f66ae34262ba0c3c7465fb5f898
First added on: Feb 20, 2024