About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult female patients aged 18 to 40 years
American Society of Anesthesiologists (ASA) physical status class I or II
Singleton pregnancy at 37 to 42 weeks gestational age
Scheduled for elective caesarean section under spinal anaesthesia
Disqualifiers
Patients with anticipated hemodynamic instability including severe preeclampsia/eclampsia, placenta previa with active bleeding, placental abruption, or hemorrhagic shock
Pre-existing cardiovascular disease including ischemic heart disease, valvular heart disease, cardiomyopathy, or arrhythmias
Baseline systolic blood pressure < 100 mmHg or heart rate > 100 bpm before spinal block
Known hypersensitivity to oxytocin
Trial design
Parallel
Treatments tested in this trial
Oxytocin
DrugOxytocin 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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