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Randomised controlled trial comparing the effects of oxytocin 5 units IV bolus vs oxytocin 5 units IV infusion on cardiac output during caesarean section - Effect on cardiac output of oxytocin bolus vs. infusion

Randomised controlled trial comparing the effects of oxytocin 5 units IV bolus vs oxytocin 5 units IV infusion on cardiac output during caesarean section - Effect on cardiac output of oxytocin bolus vs. infusion

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-002949-20-GB
Enrollment
32
Registered
2008-02-15
Start date
2008-04-28
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The drug is given routinely to women during caesarean section to help the womb contract after their baby has been delivered. This helps reduce the risk of bleeding after surgery. For this trial, the drug will be given to these women as routine, but the mode of administration will vary between an I.V. bolus or an I.V infusion to assess the effects of administration upon heart rate and blood pressure. MedDRA version: 9.1 Level: LLT Classification

Interventions

Trade Name: Syntocinon Pharmaceutical Form: Intravenous infusion INN or Proposed INN: OXYTOCIN CAS Number: 50566 Concentration unit: IU

Sponsors

Liverpool Women's NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients who are due to undergo elective caesarean section under spinal anaesthesia at more than 37 weeks gestation; ASA grade 1 or 2; age 18 or over. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Conversion to general anaesthetic; placenta praevia; diabetes mellitus; pregnancy induced hypertension; chronic hypertension; patients requiring peri-operative therapeutic anti-coagulant therapy; pre operative anaemia; liver disease; chronic renal failure; history of anaphylaxis to oxytocin.

Design outcomes

Primary

MeasureTime frame
Main Objective: Syntocinon often causes side effects such as a racing heart rate and a drop in blood pressure. Recent research suggests that giving oxytocin more slowly may reduce the risk of these side effects. This study aims to confirm this by using a newly developed advanced heart rate monitoring system called LiDCO plus.;Secondary Objective: The study will also measure the amount of bleeding that occurs after the operation to see if this is affected by the way syntocinon is administered.;Primary end point(s): Mean arterial blood pressure; cardiac output; blood loss—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026