A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section

Not Applicable

Completed

• Conditions: Prevention of Post Partum Haemorrhage
• Interventions: Drug: Oxytocin ergometrine; Drug: Oxytocin

• Registration Number: NCT02046499
• Lead Sponsor: University of Pretoria

Brief Summary

This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the prevention of post partum haemorrhage in patients undergoing caesarean section

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-23
• Study First Posted: 2014-01-27
• Primary Completion: 2014-06-30
• Study Completion: 2014-09-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 540

Inclusion Criteria

• Pregnant women delivering by caesarean section older than 18 years willing and able to give informed consent

Exclusion Criteria

• • Women not willing or women not able to provide consent

  • Women who have a classical caesarean section
  • Women younger than 18 years of age
  • Women with any of the following conditions will be excluded (ergometrine contra-indicated in patients with these conditions).
  • Pre- eclampsia
  • Eclampsia,
  • Uncontrolled hypertension (hypertension defined as systolic blood pressure more than 140 mm Hg and diastolic blood pressure more than 90 mm Hg)
  • Any cardiac lesion
  • Impaired liver function
  • Impaired kidney function
  • Hypersensitivity to any of the active ingredients of the preparations that will be used (Syntometrine® or Syntocinon®)
  • Occlusive vascular disease
  • Autoimmune vasculitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin + syntometrine	Oxytocin ergometrine	Oxytocin plus syntometrine administered
Oxytocin arm	Oxytocin	Oxytocin alone administered which is current standard of care

Primary Outcome Measures

Name	Time	Method
Blood loss	60 minutes	Estimated blood loss at caesarean section

Secondary Outcome Measures

Name	Time	Method
Side effects of oxytocin compared to oxytocin + ergometrine	24 hours	Compare side effects experienced by women administered oxytocin compared to oxytocin plus ergometrine
Need for additional uterotonics	60 minutes	To determine the need for additional uterotonics to treat post partum haemorrhage
Number of units blood transfused	24 hours	Compare the number of units blood required for transfusion between the two arms

Trial Locations

Locations (1)

Kalafong Academic Hospital; 🇿🇦 Pretoria, Gauteng, South Africa