BleedingPhase 4NCT02101567
Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Haemorrhage Following Caesarean Section
A Phase 4 study testing Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head and Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv in people with Bleeding and Anemia, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The investigators compare the effectiveness and adverse effects of I.V carbetocin versus oxytocin \& ergometrine I.V for prevention of postpartum haemorrhage following cesarean section. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- What is being tested?
- Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head and Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- May 2014to Apr 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 20 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Women with a singleton pregnancy undergoing elective cesarean section after 37 weeks of gestation.
Who cannot join
- Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
- women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
- Hypertension with pregnancy.
- Cardiac and coronary diseases with pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Carbetocin, Oxytocin and Ergometrine in Prevention of Postpartum Haemorrhage Following Caesarean Section
The investigators compare the effectiveness and adverse effects of I.V carbetocin versus oxytocin \& ergometrine I.V for prevention of postpartum haemorrhage following cesarean section.
Read the detailed description
- Postpartum hemorrhage (PPH) accounts for nearly one quarter of all maternal deaths worldwide 1 and was the second most frequent cause of maternal death in the UK for the 2000-2002 triennium.
- Caesarean section is a recognized risk factor for PPH and the worldwide caesarean delivery rate is increasing .2
- A combination of oxytocin and ergometrine is effective in preventing postpartum hemorrhage but is frequently associated with side effects such as retained placenta and hypertension.
- A recent guideline on PPH prevention developed by the World Health Organization recommended the use of oxytocin for prevention of PPH in settings in which active management of labor is not practiced.
- Ergometrine is an ergot alkaloid and hypertension and cardiac disease are contraindications due to the possible development of severe hypertension and myocardial ischemia.
- Carbetocin is a newly developed uterotonics and it may represent a promising choice as reported in the literature. It is a synthetic analogue of human oxytocin with structural modifications that increase its half-life thereby prolonging its pharmacological effects .
- A prospective double blinded randomized study . The study population will include 200 patients. The study will take place in Beni_suef University Hospitals.
- Inclusion criteria:
- Women with a singleton pregnancy undergoing elective caesarean section after 37 weeks of gestation.
- Exclusion criteria
- Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
- women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
- Hypertension with pregnancy.
- Cardiac and coronary diseases with pregnancy
- Women included in the study were divided into 2 groups:
.Group (A): including 100 patients who will receive carbetocin 100 µg I.V after delivery of the fetal head.
.Group (B): including 100 patients who will receive a combination of intraoperative oxytocin 5 I.U \& ergometrine 0.2 mg.
- Being tested
- Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head, Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv
- Keywords
- Postpartum hemorrhage, Cesarean section, Uterotonics
- Medical subject headings
- Hemorrhage, Anemia, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal headDrug
Also called Carbetocin
In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute after delivery of the head in cesarean section.
Oxytocin 5 IU iv infusion and Methtergine 0.2 mg ivDrug
Also called Oxytocin and Methyl ergometrine
In the second group of patients oxytocin 5 IU will be given iv infusion and Methergine 0.2 mg iv
| Study group | Role | What they receive |
|---|---|---|
| Pabal ( carbetocin) | Active comparator | Pabal (carbetocin which is a long acting oxytocin ) given as 100 mcg slow i.v. injection over 1 minute ( Draxis/Multiph). It will be given to the patients included in the study after delivery of the fetal head. Receives: Drug: Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head |
| Oxytocin and Methergine (methyl ergometrine) | Active comparator | The second group of patients included in the study will be given Oxytocin 5 IU ampoule by intravenous infusion and Methergine 0.2 mg IV after delivery of fetal head. Receives: Drug: Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine tone and size
The uterine tone and size will be assessed by using a hand resting on the fundus and palpating the anterior wall of the uterus one hour after the operation. The presence of a boggy uterus with either heavy vaginal bleeding or increasing uterine size can suspect diagnosis of uterine atony.
Measured: One hour after the cesarean section
Secondary outcomes (1)
Blood loss
Blood loss will be estimated postoperatively by giving each woman of each group standard 2 dressings (standard weight of dressing is 25 gm) for one hour postoperative and recording weight of blood soaked dressings and volume of lost blood.
Measured: One hour after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
- Investigators
- Nesreen A Shehata, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101567
- Sponsor's protocol ID
- Beni-Suef 3
- Status last verified
- Apr 2015
- First submitted
- 29 Mar 2014
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Carbetocin, Oxytocin and Ergometrine in Prevention of Postpartum Haemorrhage Following Caesarean Section
- ClinicalTrials.gov ID
- NCT02101567
- Acronym / sponsor ID
- Beni-Suef 3
- Keywords
- Postpartum hemorrhage, Cesarean section, Uterotonics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 Apr 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.
The investigators compare the effectiveness and adverse effects of I.V carbetocin versus oxytocin \& ergometrine I.V for prevention of postpartum haemorrhage following cesarean section.
Detailed description
- Postpartum hemorrhage (PPH) accounts for nearly one quarter of all maternal deaths worldwide 1 and was the second most frequent cause of maternal death in the UK for the 2000-2002 triennium.
- Caesarean section is a recognized risk factor for PPH and the worldwide caesarean delivery rate is increasing .2
- A combination of oxytocin and ergometrine is effective in preventing postpartum hemorrhage but is frequently associated with side effects such as retained placenta and hypertension.
- A recent guideline on PPH prevention developed by the World Health Organization recommended the use of oxytocin for prevention of PPH in settings in which active management of labor is not practiced.
- Ergometrine is an ergot alkaloid and hypertension and cardiac disease are contraindications due to the possible development of severe hypertension and myocardial ischemia.
- Carbetocin is a newly developed uterotonics and it may represent a promising choice as reported in the literature. It is a synthetic analogue of human oxytocin with structural modifications that increase its half-life thereby prolonging its pharmacological effects .
- A prospective double blinded randomized study . The study population will include 200 patients. The study will take place in Beni_suef University Hospitals.
- Inclusion criteria:
- Women with a singleton pregnancy undergoing elective caesarean section after 37 weeks of gestation.
- Exclusion criteria
- Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
- women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
- Hypertension with pregnancy.
- Cardiac and coronary diseases with pregnancy
- Women included in the study were divided into 2 groups:
.Group (A): including 100 patients who will receive carbetocin 100 µg I.V after delivery of the fetal head.
.Group (B): including 100 patients who will receive a combination of intraoperative oxytocin 5 I.U \& ergometrine 0.2 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pabal ( carbetocin) | Active comparator | Drug: Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal headPabal (carbetocin which is a long acting oxytocin ) given as 100 mcg slow i.v. injection over 1 minute ( Draxis/Multiph). It will be given to the patients included in the study after delivery of the fetal head. |
| Oxytocin and Methergine (methyl ergometrine) | Active comparator | Drug: Oxytocin 5 IU iv infusion and Methtergine 0.2 mg ivThe second group of patients included in the study will be given Oxytocin 5 IU ampoule by intravenous infusion and Methergine 0.2 mg IV after delivery of fetal head. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- • Women with a singleton pregnancy undergoing elective cesarean section after 37 weeks of gestation.
Key exclusion criteria (4 listed)
- Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
- women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
- Hypertension with pregnancy.
- Cardiac and coronary diseases with pregnancy
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 |
|---|---|---|
| Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal headAlso: CarbetocinIn the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute after delivery of the head in cesarean section. | Drug | Pabal ( carbetocin) |
| Oxytocin 5 IU iv infusion and Methtergine 0.2 mg ivAlso: Oxytocin and Methyl ergometrineIn the second group of patients oxytocin 5 IU will be given iv infusion and Methergine 0.2 mg iv | Drug | Oxytocin and Methergine (methyl ergometrine) |
Primary outcome
Uterine tone and size
Time frame: One hour after the cesarean section
The uterine tone and size will be assessed by using a hand resting on the fundus and palpating the anterior wall of the uterus one hour after the operation. The presence of a boggy uterus with either heavy vaginal bleeding or increasing uterine size can suspect diagnosis of uterine atony.
1 secondary outcome
Blood loss
Time frame: One hour after cesarean section
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 10 Apr 2015.
- Epidemiology of postpartum haemorrhage: a systematic review. Carroli G1, Cuesta C,2008 Dec;22(6):999-1012. doi: 10.1016/j.bpobgyn.2008.08.004. Epub 2008 Sep 25. Abalos E, Gulmezoglu AM.Link provided by the sponsor.
- • Villar J, Valladares E, Wojdyla D, Zavaleta N, Carroli G, Velazco A, et al. Caesarean delivery rates and pregnancy outcomes: the 2005 WHO global survey on maternal and perinatal health in Latin America. Lancet 2006; 367:1819-29.Link provided by the sponsor.
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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.
Nesreen A Shehata, MD principal investigator
Beni-Suef University
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 Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head and Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv in people with Bleeding and Anemia, run by Beni-Suef 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 1 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 10 Apr 2015. 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?
Uterine tone and size (time frame: One hour after the cesarean section). 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 10 Apr 2015.