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

March 8, 2021 updated by: Leon Snyman, University of Pretoria
This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the prevention of post partum haemorrhage in patients undergoing caesarean section

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0001
        • Kalafong Academic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxytocin arm
Oxytocin alone administered which is current standard of care
Drug: Oxytocin
Oxytocin will be administered intravenously as per standard protocol
Experimental: Oxytocin + syntometrine
Oxytocin plus syntometrine administered
Drug: Oxytocin ergometrine
Oxytocin ergometrine will be administered intra-musculalry
Other Names:
  • Syntometrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: 60 minutes
Estimated blood loss at caesarean section
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours
Need for additional uterotonics
Time Frame: 60 minutes
To determine the need for additional uterotonics to treat post partum haemorrhage
60 minutes
Number of units blood transfused
Time Frame: 24 hours
Compare the number of units blood required for transfusion between the two arms
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pretoria

Investigators

  • Principal Investigator: Leon C Snyman, MbChB MMed, Department Obstetrics & Gynaecology, University of Pretoria, South Africa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

June 30, 2014

Study Completion (Actual)

September 30, 2014

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPH Prevention Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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