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

Primary Purpose

Prevention of Post Partum Haemorrhage

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Oxytocin
Oxytocin ergometrine
Sponsored by
University of Pretoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Post Partum Haemorrhage focused on measuring Prevention, post partum haemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Kalafong Academic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Oxytocin arm

Oxytocin + syntometrine

Arm Description

Oxytocin alone administered which is current standard of care

Oxytocin plus syntometrine administered

Outcomes

Primary Outcome Measures

Blood loss
Estimated blood loss at caesarean section

Secondary Outcome Measures

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

Full Information

First Posted
January 23, 2014
Last Updated
March 8, 2021
Sponsor
University of Pretoria
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1. Study Identification

Unique Protocol Identification Number
NCT02046499
Brief Title
A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section
Official Title
A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
June 30, 2014 (Actual)
Study Completion Date
September 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pretoria

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Post Partum Haemorrhage
Keywords
Prevention, post partum haemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
540 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin arm
Arm Type
Active Comparator
Arm Description
Oxytocin alone administered which is current standard of care
Arm Title
Oxytocin + syntometrine
Arm Type
Experimental
Arm Description
Oxytocin plus syntometrine administered
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
Oxytocin will be administered intravenously as per standard protocol
Intervention Type
Drug
Intervention Name(s)
Oxytocin ergometrine
Other Intervention Name(s)
Syntometrine
Intervention Description
Oxytocin ergometrine will be administered intra-musculalry
Primary Outcome Measure Information:
Title
Blood loss
Description
Estimated blood loss at caesarean section
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Side effects of oxytocin compared to oxytocin + ergometrine
Description
Compare side effects experienced by women administered oxytocin compared to oxytocin plus ergometrine
Time Frame
24 hours
Title
Need for additional uterotonics
Description
To determine the need for additional uterotonics to treat post partum haemorrhage
Time Frame
60 minutes
Title
Number of units blood transfused
Description
Compare the number of units blood required for transfusion between the two arms
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon C Snyman, MbChB MMed
Organizational Affiliation
Department Obstetrics & Gynaecology, University of Pretoria, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kalafong Academic Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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