Effect of Oxytocin Bolus Versus Slow Infusion on Haemodynamic Stability During Caesarean Section Under Spinal Anaesthesia

What Was Tested

The trial (not phased) is built around Oxytocin.

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.

It had two arms (groups): Bolus Group (active comparator) and Infusion Group (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Written informed consent obtained.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2026-09-01 with completion listed for 2027-04-01.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Systolic Blood Pressure (SBP) from Baseline (time frame: Baseline; 2 minutes, 5 minutes, and 10 minutes after oxytocin administration).

It also tracked 3 secondary outcomes, for example Change in Diastolic Blood Pressure and Heart Rate from Baseline and Uterine Contraction Scale Score.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 60 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.