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OpenTrials
Completed

NCT Number: NCT02046499

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

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

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Key information

Conditions

Prevention of Post Partum Haemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kalafong Academic Hospital

Pretoria, Gauteng, 0001, South Africa

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Oxytocin

Drug

Oxytocin will be administered intravenously as per standard protocol

Oxytocin ergometrine

Drug

Oxytocin ergometrine will be administered intra-musculalry

Other names: Syntometrine

Primary outcomes

  1. Blood loss

    Time frame: 60 minutes

    Estimated blood loss at caesarean section

Secondary outcomes

  1. Side effects of oxytocin compared to oxytocin + ergometrine

    Time frame: 24 hours

    Compare side effects experienced by women administered oxytocin compared to oxytocin plus ergometrine

  2. Need for additional uterotonics

    Time frame: 60 minutes

    To determine the need for additional uterotonics to treat post partum haemorrhage

  3. Number of units blood transfused

    Time frame: 24 hours

    Compare the number of units blood required for transfusion between the two arms

Sponsors and collaborators

Lead sponsor

University of Pretoria

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 27, 2014
Registry last updated
Mar 9, 2021

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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