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NCT Number: NCT07784478

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hayatabad Medical Complex / Khyber Girls Medical College

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location contact

Fareeha Zahir, MBBS / FCPS-II Trainee

CONTACT

[email protected]

+923319932275

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Failed spinal anaesthesia requiring conversion to general anaesthesia
  • Patients receiving medications that may alter the hemodynamic response to oxytocin (beta-blockers, calcium channel blockers, ACE inhibitors, or angiotensin receptor blockers)
  • Pre-existing anaemia (Hb < 8 g/dL)

Treatment and study plan

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.

Other names: Syntocinon

Primary outcomes

  1. Change in Systolic Blood Pressure (SBP) from Baseline

    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.

Secondary outcomes

  1. Change in Diastolic Blood Pressure and Heart Rate from Baseline

    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.

  2. Incidence of Clinically Significant Hypotension

    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.

  3. Uterine Contraction Scale Score

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fareeha Zahir, MBBS / FCPS-II Trainee

CONTACT

[email protected]

+923319932275

Sponsors and collaborators

Lead sponsor

Khyber Girls Medical College

Other

Registry information

Official study title

Effect of Oxytocin Administration Technique on Haemodynamic Stability During Caesarean Section Under Spinal Anaesthesia: A Randomised Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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