Postpartum HemorrhagePhase 4NCT02044549
Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section
A Phase 4 study testing carbetocin and Syntometrine in people with Postpartum Hemorrhage and Blood Loss, run by Cairo University at 1 site in Egypt.
Trial summary
to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Blood Loss
- What is being tested?
- carbetocin and Syntometrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2014to Dec 2015
- Phase
- Phase 4
- 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 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants are at 37 - 40 weeks of gestational age
- Noncomplicated pregnancy.
Who cannot join
- Participants with placenta previa
- Patients with coagulopathy
- preeclamptic women
- known sensitivity to oxytocin or methergine were excluded
Trial locations and contacts
1 site in 1 country.
About this study
to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section
Read the detailed description
A double blind randomized study conducted on 450 pregnant subjected randomly either to single 100 μg IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.
Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic
- Conditions
- Postpartum Hemorrhage, Blood Loss
- Being tested
- carbetocin, Syntometrine
- Keywords
- Carbetocin, syntometrine, postpartum hemorrhage, cesarean section
- Medical subject headings
- Postpartum Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbetocinDrug
Also called Pabal
Oxycontin analogue
SyntometrineDrug
Also called Oxytocin methergine combination
Uterotonins
| Study group | Role | What they receive |
|---|---|---|
| carbetocin | Active comparator | single 100 μg IV dose of carbetocin (150 women) after fetal extraction and before placental removal. Receives: Drug: carbetocin |
| Syntometrine | Active comparator | Intravenous combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal. Receives: Drug: Syntometrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of post partum hemorrhage after CS
Number of participants experienced postpartum hemorrhage
Measured: 24 hours
Secondary outcomes (1)
side effects of drugs used
Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching
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 posted24 Jan 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Ass prof kasr aini medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044549
- Sponsor's protocol ID
- Carbitocin
- Status last verified
- Jun 2021
- First submitted
- 15 Jan 2014
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section
- ClinicalTrials.gov ID
- NCT02044549
- Acronym / sponsor ID
- Carbitocin
- Conditions
- Postpartum Hemorrhage, Blood Loss
- Keywords
- Carbetocin, syntometrine, postpartum hemorrhage, cesarean section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 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.
to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section
Detailed description
A double blind randomized study conducted on 450 pregnant subjected randomly either to single 100 μg IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.
Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carbetocin | Active comparator | Drug: carbetocinsingle 100 μg IV dose of carbetocin (150 women) after fetal extraction and before placental removal. |
| Syntometrine | Active comparator | Drug: SyntometrineIntravenous combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All participants are at 37 - 40 weeks of gestational age
- Noncomplicated pregnancy.
Key exclusion criteria (4 listed)
- Participants with placenta previa
- Patients with coagulopathy
- preeclamptic women
- known sensitivity to oxytocin or methergine were excluded
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 |
|---|---|---|
| carbetocinAlso: PabalOxycontin analogue | Drug | carbetocin |
| SyntometrineAlso: Oxytocin methergine combinationUterotonins | Drug | Syntometrine |
Primary outcome
prevention of post partum hemorrhage after CS
Time frame: 24 hours
Number of participants experienced postpartum hemorrhage
1 secondary outcome
side effects of drugs used
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 24 Jun 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.
Ahmed Maged, MD principal investigator
Ass prof kasr aini medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carbetocin and Syntometrine in people with Postpartum Hemorrhage and Blood Loss, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 4 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 24 Jun 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
prevention of post partum hemorrhage after CS (time frame: 24 hours). 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 24 Jun 2021.