Prevention of Post Partum HaemorrhageNCT02046499
A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section
A study testing Oxytocin and Oxytocin ergometrine in people with Prevention of Post Partum Haemorrhage, run by University of Pretoria at 1 site in South Africa.
Trial summary
This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the prevention of post partum haemorrhage in patients undergoing caesarean section Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prevention of Post Partum Haemorrhage
- What is being tested?
- Oxytocin and Oxytocin ergometrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Jan 2014to 30 Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women delivering by caesarean section older than 18 years willing and able to give informed consent
Who cannot join
- • 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,
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- 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 locations and contacts
1 site in 1 country.
About this study
This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the prevention of post partum haemorrhage in patients undergoing caesarean section
- Conditions
- Prevention of Post Partum Haemorrhage
- Being tested
- Oxytocin, Oxytocin ergometrine
- Keywords
- Prevention, post partum haemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Oxytocin will be administered intravenously as per standard protocol
Oxytocin ergometrineDrug
Also called Syntometrine
Oxytocin ergometrine will be administered intra-musculalry
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin arm | Active comparator | Oxytocin alone administered which is current standard of care Receives: Drug: Oxytocin |
| Oxytocin + syntometrine | Experimental | Oxytocin plus syntometrine administered Receives: Drug: Oxytocin ergometrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Estimated blood loss at caesarean section
Measured: 60 minutes
Secondary outcomes (3)
Side effects of oxytocin compared to oxytocin + ergometrine
Compare side effects experienced by women administered oxytocin compared to oxytocin plus ergometrine
Measured: 24 hours
Need for additional uterotonics
To determine the need for additional uterotonics to treat post partum haemorrhage
Measured: 60 minutes
Number of units blood transfused
Compare the number of units blood required for transfusion between the two arms
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study start1 Jan 2014
- Primary completion30 Jun 2014
- Study completion30 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Post Partum HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pretoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leon Snyman, University of Pretoria
- Investigators
- Leon C Snyman, MbChB MMed, Principal investigator, Department Obstetrics & Gynaecology, University of Pretoria, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046499
- Sponsor's protocol ID
- PPH Prevention Trial
- Status last verified
- Mar 2021
- First submitted
- 23 Jan 2014
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section
- ClinicalTrials.gov ID
- NCT02046499
- Acronym / sponsor ID
- PPH Prevention Trial
- Conditions
- Prevention of Post Partum Haemorrhage
- Keywords
- Prevention, post partum haemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- University of PretoriaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Sep 2014 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the prevention of post partum haemorrhage in patients undergoing caesarean section
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin arm | Active comparator | Drug: OxytocinOxytocin alone administered which is current standard of care |
| Oxytocin + syntometrine | Experimental | Drug: Oxytocin ergometrineOxytocin plus syntometrine administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women delivering by caesarean section older than 18 years willing and able to give informed consent
Key exclusion criteria (13 listed)
- • Women not willing or women not able to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinOxytocin will be administered intravenously as per standard protocol | Drug | Oxytocin arm |
| Oxytocin ergometrineAlso: SyntometrineOxytocin ergometrine will be administered intra-musculalry | Drug | Oxytocin + syntometrine |
Primary outcome
Blood loss
Time frame: 60 minutes
Estimated blood loss at caesarean section
3 secondary outcomes
Side effects of oxytocin compared to oxytocin + ergometrine
Time frame: 24 hours
Need for additional uterotonics
Time frame: 60 minutes
Number of units blood transfused
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leon C Snyman, MbChB MMed principal investigator
Department Obstetrics & Gynaecology, University of Pretoria, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin and Oxytocin ergometrine in people with Prevention of Post Partum Haemorrhage, run by University of Pretoria at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.