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

University of Pretoria (UP)

Status: Completed

Conditions: Prevention of Post Partum Haemorrhage

Treatments: Drug: Oxytocin; Drug: Oxytocin ergometrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02046499

PPH Prevention Trial

Details and patient eligibility

About

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

Enrollment: 540 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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540 participants in 2 patient groups

Oxytocin arm

Active Comparator group

Description:

Oxytocin alone administered which is current standard of care

Treatment:

Drug: Oxytocin

Oxytocin + syntometrine

Experimental group

Description:

Oxytocin plus syntometrine administered

Treatment:

Drug: Oxytocin ergometrine