Hayatabad Medical Complex / Khyber Girls Medical College
Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan
NCT Number: NCT07784478
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.
Trial opening soon.
Get Notified18 year–40 year
Female
Interventional
Not applicable
Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Syntocinon
Time frame: Baseline; 2 minutes, 5 minutes, and 10 minutes after oxytocin administration
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: 1, 2, 3, 5, 10, 15, and 20 minutes after oxytocin administration
Change in diastolic blood pressure and heart rate from baseline at defined time points after oxytocin administration.
Time frame: Within 20 minutes after oxytocin administration
Proportion of participants who develop systolic blood pressure < 90 mmHg or a fall of > 20% from baseline after oxytocin administration.
Time frame: 5 minutes after placental delivery
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.
Contact information is provided by the study sponsor or research team.
Khyber Girls Medical College
Other
Effect of Oxytocin Administration Technique on Haemodynamic Stability During Caesarean Section Under Spinal Anaesthesia: A Randomised Controlled Trial
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