Postpartum HemorrhagePhase 4NCT04300452
Carbetocin Versus Ergometrin in the Prevention of Postpartum Hemorrhage
A Phase 4 study testing Carbetocin and Ergometrine Maleate in people with Postpartum Hemorrhage, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
In the present study will be compared Carbetocin with ergometrin in the prevention of postpartum haemorrhage (PPH) in parturients that are undergoing caesarean section and are not presenting risk factors for PPH. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Carbetocin and Ergometrine Maleate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 5 Apr 2018to 30 Sep 2020
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female gender Gestating Between 18-40 years No co-morbidity
Who cannot join
- Under age parturients
- Parturients >40 years of age
- Multiple pregnancies
- Parturients with abnormal placental adhesion
- Parturients with two or more caesarian sections in the past
- Parturients with haematological diseases
Show all 10Show fewer
- Parturients that receive anticoagulation therapy for a concomitant disease
- Parturients with severe co-morbidity
- Refusal to sign the consent form
- Caesarian section under general anaesthesia
Trial locations and contacts
1 site in 1 country.
Ilektra Iordanidou contact
Greece1 site, 1 recruiting
- Recruiting
Hospital "Elena Venizelou"
Athens, Attica, 11525
Christos KOLIAFAS, 2105322719, ckoliafas@yahoo.gr
About this study
Official title: Carbetocin Versus Ergometrin in the Prevention of Postpartum Hemorrhage in Parturients Undergoing Caesarian Section Under Regional Anaesthesia. A Single Blind Randomized Control Trial
In the present study will be compared Carbetocin with ergometrin in the prevention of postpartum haemorrhage (PPH) in parturients that are undergoing caesarean section and are not presenting risk factors for PPH. As indicators will be used intraoperative blood loss, as well as the value of hemoglobin and hematocrit 24 hours after the caesarian section.
Read the detailed description
In the particular study the investigators will compare the effect of Carbetocin and ergometrin in the prevention of postpartum haemorrhage. It is a prospective comparative single blind randomized study which will be carried out in the G.N.M.A. "Elena Venizelou". The protocol will be filed in an international database before the initiation of the study (eg. ClinicalTrials.gov). The sample will be constituted by parturients that will undergo Caesarean section. The parturients will be divided in two groups: the group to which carbetocin will be administered and the group to which ergometrin will be used as the main uterotonic drug. Randomization will be achieved with the help of a computer and the method ¨sealed envelope¨. In this method the investigator receives a sealed envelope either by mail or by computer, in which a random number will be placed. This number will correspond to one of the treatments. For greater reliability in the results some exclusion criteria will be set.
A consent form will be given to the parturients that will have to sign after it is explained to them the purpose of the study and that there is a rescue treatment in case of failure of the medication is administered to them. Subsequently a complete medical background will be obtained and it will be performed the standard laboratory control which includes: a blood count, coagulation parameters, biochemical parameters and an assessment by a cardiologist.
Regional anaesthesia will then be performed (spinal, epidural or combined spinal-epidural). After the embryo exit and placental detachment in the ergometrine group will be administered intravenously 0.2 mg of the substance slowly in a bolus administration, while in the carbetocin group will be administered 100 mcg of carbetocin diluted in 100 cc of N/S 0.9% in a continuous rapid-flow intravenous infusion.
The efficacy of the uterotonic drugs will be assessed with a new hemoglobin and hematocrit count 24 hours after the end of the cesarean section, as well as by intraoperative blood loss which will be calculated by weighing gauzes and compresses after the end of the operation, by the amount of blood present in the suction unit and by the blood present in the surroundings of the operating table (9). It is obvious that if necessary rescue therapy will be administered which will consist of 15 iu of oxytocin in intravenous infusion in the ergometrin group and 0.2 mg of ergometrin in slow bolus administration in the carbetocin group, as well as 3 tb of misoprostol in both groups administered per rectum.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Carbetocin, Ergometrine Maleate
- Keywords
- carbetocin, ergometrin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Also called Pabal
Administration of Carbetocin after placental detachment
Ergometrine MaleateDrug
Also called Mitrotan
Administration of ergometrin after placental detachment
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin group | Active comparator | In the carbetocin group will be administered 100 mcg of carbetocin diluted in 100 cc of N/S 0.9% in a continuous rapid-flow intravenous infusion. Receives: Drug: Carbetocin |
| Ergometrin group | Active comparator | In the ergometrine maleate group will be administered intravenously 0.2 mg of the substance slowly in a bolus administration. Receives: Drug: Ergometrine Maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of the uterotonic drugs wil be assessed with a new hemoglobin in gr/dl 24 hours after completion of caesarian section
The efficacy of the uterotonic drugs will be assessed with a new hemoglobin in g/dl 24 hours after the end of the cesarean section, as well as by intraoperative blood loss in ml which will be calculated by weighing gauzes and compresses after the end of the operation, by the amount of blood in ml present in the suction unit and by the blood present in the surroundings of the operating table.
Measured: 2 years
The efficacy of the uterotonic drugs will be assessed with a new hematocrit count measured in % percentage 24 hours after completion of caesarian section.
The efficace of the uterotonic drugs will be assessed with a new hematocrit count measured in % percentage 24 hours after completion of caesarian section.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start5 Apr 2018
- Primary completion10 Jun 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
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 National and Kapodistrian University of AthensThe 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
- Model description
- The parturients will be divided in two groups: the group to which carbetocin will be administered and the group to which ergometrin will be used as the main uterotonic drug. Randomization will be achieved with the help of a computer and the method ¨sealed envelope¨. In this method the investigator receives a sealed envelope either by mail or by computer, in which a random number will be placed. This number will correspond to one of the treatments. For greater relialibility in the results some exclusion criteria will be set.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christos Koliafas, National and Kapodistrian University of Athens
- Investigators
- Nikoleta Iakovidou, Study director, Professor of Pediatrics NKUAthens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300452
- Sponsor's protocol ID
- carbetocin-ergometrin
- Status last verified
- Mar 2020
- First submitted
- 30 Apr 2018
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin Versus Ergometrin in the Prevention of Postpartum Hemorrhage in Parturients Undergoing Caesarian Section Under Regional Anaesthesia. A Single Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04300452
- Acronym / sponsor ID
- carbetocin-ergometrin
- Conditions
- Postpartum Hemorrhage
- Keywords
- carbetocin, ergometrin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 10 Jun 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 9 Mar 2020 (actual)
- 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.
In the present study will be compared Carbetocin with ergometrin in the prevention of postpartum haemorrhage (PPH) in parturients that are undergoing caesarean section and are not presenting risk factors for PPH. As indicators will be used intraoperative blood loss, as well as the value of hemoglobin and hematocrit 24 hours after the caesarian section.
Detailed description
In the particular study the investigators will compare the effect of Carbetocin and ergometrin in the prevention of postpartum haemorrhage. It is a prospective comparative single blind randomized study which will be carried out in the G.N.M.A. "Elena Venizelou". The protocol will be filed in an international database before the initiation of the study (eg. ClinicalTrials.gov). The sample will be constituted by parturients that will undergo Caesarean section. The parturients will be divided in two groups: the group to which carbetocin will be administered and the group to which ergometrin will be used as the main uterotonic drug. Randomization will be achieved with the help of a computer and the method ¨sealed envelope¨. In this method the investigator receives a sealed envelope either by mail or by computer, in which a random number will be placed. This number will correspond to one of the treatments. For greater reliability in the results some exclusion criteria will be set.
A consent form will be given to the parturients that will have to sign after it is explained to them the purpose of the study and that there is a rescue treatment in case of failure of the medication is administered to them. Subsequently a complete medical background will be obtained and it will be performed the standard laboratory control which includes: a blood count, coagulation parameters, biochemical parameters and an assessment by a cardiologist.
Regional anaesthesia will then be performed (spinal, epidural or combined spinal-epidural). After the embryo exit and placental detachment in the ergometrine group will be administered intravenously 0.2 mg of the substance slowly in a bolus administration, while in the carbetocin group will be administered 100 mcg of carbetocin diluted in 100 cc of N/S 0.9% in a continuous rapid-flow intravenous infusion.
The efficacy of the uterotonic drugs will be assessed with a new hemoglobin and hematocrit count 24 hours after the end of the cesarean section, as well as by intraoperative blood loss which will be calculated by weighing gauzes and compresses after the end of the operation, by the amount of blood present in the suction unit and by the blood present in the surroundings of the operating table (9). It is obvious that if necessary rescue therapy will be administered which will consist of 15 iu of oxytocin in intravenous infusion in the ergometrin group and 0.2 mg of ergometrin in slow bolus administration in the carbetocin group, as well as 3 tb of misoprostol in both groups administered per rectum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The parturients will be divided in two groups: the group to which carbetocin will be administered and the group to which ergometrin will be used as the main uterotonic drug. Randomization will be achieved with the help of a computer and the method ¨sealed envelope¨. In this method the investigator receives a sealed envelope either by mail or by computer, in which a random number will be placed. This number will correspond to one of the treatments. For greater relialibility in the results some exclusion criteria will be set.
| Arm | Type | Receives |
|---|---|---|
| Carbetocin group | Active comparator | Drug: CarbetocinIn the carbetocin group will be administered 100 mcg of carbetocin diluted in 100 cc of N/S 0.9% in a continuous rapid-flow intravenous infusion. |
| Ergometrin group | Active comparator | Drug: Ergometrine MaleateIn the ergometrine maleate group will be administered intravenously 0.2 mg of the substance slowly in a bolus administration. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female gender Gestating Between 18-40 years No co-morbidity
Key exclusion criteria (10 listed)
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: PabalAdministration of Carbetocin after placental detachment | Drug | Carbetocin group |
| Ergometrine MaleateAlso: MitrotanAdministration of ergometrin after placental detachment | Drug | Ergometrin group |
Primary outcome
The efficacy of the uterotonic drugs wil be assessed with a new hemoglobin in gr/dl 24 hours after completion of caesarian section
Time frame: 2 years
The efficacy of the uterotonic drugs will be assessed with a new hemoglobin in g/dl 24 hours after the end of the cesarean section, as well as by intraoperative blood loss in ml which will be calculated by weighing gauzes and compresses after the end of the operation, by the amount of blood in ml present in the suction unit and by the blood present in the surroundings of the operating table.
The efficacy of the uterotonic drugs will be assessed with a new hematocrit count measured in % percentage 24 hours after completion of caesarian section.
Time frame: 2 years
The efficace of the uterotonic drugs will be assessed with a new hematocrit count measured in % percentage 24 hours after completion of caesarian section.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Ilektra Iordanidou contact
Nikoleta Iakovidou study director
Professor of Pediatrics NKUAthens
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 Ergometrine Maleate in people with Postpartum Hemorrhage, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 10 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: status not confirmed, as of the sponsor's last update on 9 Mar 2020. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christos KOLIAFAS (6972787798 ext. 003, ckoliafas@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of the uterotonic drugs wil be assessed with a new hemoglobin in gr/dl 24 hours after completion of caesarian section (time frame: 2 years). The study lists 2 primary outcomes in all. 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 2020.