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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorKhyber Girls Medical College

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Oxytocin

    Drug

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Bolus GroupActive comparator 1 intervention
Group B: Infusion GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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