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.
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. This 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. Sixty 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: Group A (Bolus): Oxytocin 5 IU given as an intravenous bolus over 15 seconds immediately after umbilical cord clamping. Group B (Infusion): Oxytocin 5 IU diluted and infused over 15 minutes via syringe pump immediately after umbilical cord clamping. The 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. The 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
Hayatabad Medical Complex / Khyber Girls Medical College
Peshawar, Khyber Pakhtunkhwa, Pakistan
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.
Time frame: Baseline; 2 minutes, 5 minutes, and 10 minutes after oxytocin administration
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.
Time frame: 1, 2, 3, 5, 10, 15, and 20 minutes after oxytocin administration
Incidence of Clinically Significant Hypotension
Proportion of participants who develop systolic blood pressure \< 90 mmHg or a fall of \> 20% from baseline after oxytocin administration.
Time frame: Within 20 minutes after oxytocin administration
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.
Time frame: 5 minutes after placental delivery
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