Postpartum Hemorrhage (Primary)Phase 4NCT03755531
Carbetocin Versus Oxytocin for the Prevention of Postpartum Hemorrhage in Emergency Caesarean Delivery
A Phase 4 study testing Carbetocin and Oxytocin in people with Postpartum Hemorrhage (Primary), run by Al-Kindy College of Medicine at 1 site in Iraq.
Trial summary
Postpartum haemorrhage keeps to be the leading cause of maternal mortality in middle and low-income countries, including Iraq. Much advancement had been made in the field of treatment for postpartum haemorrhage but no much progress had been made in the field of prevention, where one of its main component is the… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Postpartum Hemorrhage (Primary)
- What is being tested?
- Carbetocin and Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIraq
- Study dates
- 4 Jan 2018to 1 Aug 2018
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients age ≥18 years
- Singleton pregnancy
- Full term gestation
- Emergency cesarean section during labor
Who cannot join
- Cases of coagulopathy
- Drug hypersensitivity
- Medical diseases as; cardiac, hypertension, liver, renal or endocrine diseases
- Uterine fibroids
- Suspected placental pathology (accreta, previa or abruptio)
- General anesthesia
- Longitudinal uterine incision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heat Stable Carbetocin Versus Oxytocin for the Prevention of Primary Postpartum Hemorrhage in Emergency Caesarean Delivery
Postpartum haemorrhage keeps to be the leading cause of maternal mortality in middle and low-income countries, including Iraq. Much advancement had been made in the field of treatment for postpartum haemorrhage but no much progress had been made in the field of prevention, where one of its main component is the administration of uterotonic, preferably oxytocin, immediately after birth of the baby.
In many low- and middle income countries, the efficacy of oxytocin cannot be assured since access to sustained cold-chain is unavailable. Regarding the other uterotonics; ergometrine degrades when exposed to heat or light. Misoprostol degrades rapidly when exposed to Moisture.
Read more
Innovation in the manufacture of carbetocin had meet the stability requirements for hot and humid climates.
This study had been accomplished to evaluate the uterotonic effect of carbetocin compared with oxytocin for the prevention of postpartum haemorrhage in emergency caesarean delivery. Looking if carbetocin is superior to oxytocin in term of reduction in the need for additional uterotonic agents or the occurrence of PPH.
Read the detailed description
Setting and design:
It is a double blinded randomized parallel clinical trial. That had been conducted at Al Elweyia Maternity Teaching Hospital in Baghdad during the period from Jan., 4th, 2018 to August, 1st, 2018. Written consent was insured for all the participants.
Data collection:
Three hundred and twenty pregnant women who were underwent emergency caesarean sections under regional anesthesia were enrolled in the study (due to limitation of carbetocin ampoules that were available). Those women were randomized to oxytocin or carbetocin in a rate of 2:1 (for prophylaxis of PPH in the active management of third stage of labour). Twenty cases were omitted since they were not fulfilled the eligibility criteria and only three hundred women were completed the study. They were divided into two groups:
Group1 (case group): 100 pregnant women, whom they received carbetocin for the prevention of PPH.
Group 2 (control group): 200 pregnant women, whom they received oxytocin for the prevention of PPH.
Additional information including age, parity, past medical history, and body mass index (BMI) were taken.
Intervention:
The following steps were followed:
- Hemoglobin and hematocrit were assessed before caesarean section.
- One ml of either carbitocin (100 mcg) or oxytocin (10 IU) was given as a bolus intravenous injection by the anesthesiologist after labor of the baby at once.
- The placentae were delivered by controlled cord traction.
- It was the operating obstetrician decision to evaluated the uterine tone, bleeding intra-operatively and the need for an additional uterotonic and method of its administration, dose and duration.
- Our center usual regimen for uterine atony is an oxytocin (40 IU in 500 ml isotonic crystalloid solution) intravenous infusion over 4-5 hours.
Follow up:
For 24 hours was done, that is include:
- Evaluation of blood loss by the obstetrician and the anesthesiologist after skin closure, that is include the entire amount that had been suctioned, taken by the surgical gauzes or spilled in the surgical field, using visual estimation chart for assessment of blood loss.
- The need of any additional uterotonic drugs after the operation was recorded.
- The need of blood transfusion post delivery.
- The blood pressure and pulse rate of the women involved in the study were documented at 0, 5, 10, 20, 30 and 60 minutes after the injection of the drug.
- The period of operation (skin cut into the final closure of the skin) was recorded.
- Intravenous fluid infusion was administered regularly and as it had been stated by the obstetricians and maintained after the operation until oral intake was started.
- Hemoglobin and hematocrit was assessed the day after the caesarean section.
Statistical analysis:
Statistical Package for Social Sciences (SPSS) version 21 was used. Descriptive statistics presented as (mean ± standard deviation) and frequencies as percentages. The database was examined for errors using range and logical data cleaning methods, and inconsistencies were remedied. Chi square test was used to compare between categorical variables (Fishers exact test used when expected variable was less than 20% of total) and t-test was used to compare between two means. Cohen's d, a standardized measure of effect size for difference between 2 means, which can be compared across different variables and studies, since it has no unit of measurement was used. Significance level was set at P < 0.05.
- Conditions
- Postpartum Hemorrhage (Primary)
- Being tested
- Carbetocin, Oxytocin
- Keywords
- Oxytocin, Carbetocin, Emergency Caesarean Section
- 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 BABAL
Heat stable Carbetocin, a clear colourless solution. Oxytocic activity: approximately 50 IU of oxytocin/vial. One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection, slowly over 1 minute after labor of the baby at once. It was used once and no further doses were given.
Drug was kept in cold storage (2 to 8°C).
OxytocinDrug
Also called Pitocin
Oxytocin, a clear colourless solution. One ml of oxytocin (10 IU), was given as a bolus intravenous injection over 1 minute, after labor of the baby at once. Further doses can be given accordingly.
Drug was kept in cold storage (2 to 8°C).
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin | Experimental | One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection after labor of the baby at once. Receives: Drug: Carbetocin |
| Oxytocin | Active comparator | One ml of Oxytocin (10 IU), was given as a bolus intravenous injection after labor of the baby at once. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss equal or more than 1000 ml
Proportion of women with blood loss equal or more than 1000 ml in both study groups
Measured: During the first 24 hours
Use of additional uterotonics
Proportion of the women whom they need additional uterotonic agents
Measured: During the first 24 hours
Secondary outcomes (3)
Blood pressure changes in carbetocin versus oxytocin group
Systolic and diastolic blood pressure changes that may occur in both groups
Measured: Within one hour after administration of the drugs
Pulse rate changes in carbetocin versus oxytocin group
Detection of pulse rate changes that may occur in both groups
Measured: Within one hour after administration of the drugs
Blood transfusion need
Proportion of the women whom they need blood transfusion
Measured: During the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start4 Jan 2018
- Primary completion10 Jun 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Hemorrhage (Primary)Studies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Kindy College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Elweyia Maternity Teaching Hospital
- Responsible party
- Principal investigator, Taghreed Alhaidari, Al-Kindy College of Medicine
- Investigators
- Taghreed K Alhaidari, CABOG, Study chair, Al Kindy College of Medicine, University of BaghdadShayma S Al-Zubaidy, FICOG, MD, Principal investigator, Al- Elweyia Maternity Teaching HospitalAlaa A Hussein, FICOG, MD, Principal investigator, Al- Elweyia Maternity Teaching HospitalUlfat M Alnakkash, CABOG, Principal investigator, Al- Elweyia Maternity Teaching HospitalAhmed S Alnuaimi, PhD, Principal investigator, Baghdad College of Medicine/ University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755531
- Sponsor's protocol ID
- 4 Al-KindyCM
- Status last verified
- Nov 2018
- First submitted
- 24 Nov 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the main outcomes' result reported in this article will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Stable Carbetocin Versus Oxytocin for the Prevention of Primary Postpartum Hemorrhage in Emergency Caesarean Delivery
- ClinicalTrials.gov ID
- NCT03755531
- Acronym / sponsor ID
- 4 Al-KindyCM
- Conditions
- Postpartum Hemorrhage (Primary)
- Keywords
- Oxytocin, Carbetocin, Emergency Caesarean Section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Al-Kindy College of MedicineUniversity, hospital or other
- Collaborators
- Elweyia Maternity Teaching Hospital
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 10 Jun 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 28 Nov 2018 (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.
Postpartum haemorrhage keeps to be the leading cause of maternal mortality in middle and low-income countries, including Iraq. Much advancement had been made in the field of treatment for postpartum haemorrhage but no much progress had been made in the field of prevention, where one of its main component is the administration of uterotonic, preferably oxytocin, immediately after birth of the baby.
In many low- and middle income countries, the efficacy of oxytocin cannot be assured since access to sustained cold-chain is unavailable. Regarding the other uterotonics; ergometrine degrades when exposed to heat or light. Misoprostol degrades rapidly when exposed to Moisture.
Innovation in the manufacture of carbetocin had meet the stability requirements for hot and humid climates.
This study had been accomplished to evaluate the uterotonic effect of carbetocin compared with oxytocin for the prevention of postpartum haemorrhage in emergency caesarean delivery. Looking if carbetocin is superior to oxytocin in term of reduction in the need for additional uterotonic agents or the occurrence of PPH.
Detailed description
Setting and design:
It is a double blinded randomized parallel clinical trial. That had been conducted at Al Elweyia Maternity Teaching Hospital in Baghdad during the period from Jan., 4th, 2018 to August, 1st, 2018. Written consent was insured for all the participants.
Data collection:
Three hundred and twenty pregnant women who were underwent emergency caesarean sections under regional anesthesia were enrolled in the study (due to limitation of carbetocin ampoules that were available). Those women were randomized to oxytocin or carbetocin in a rate of 2:1 (for prophylaxis of PPH in the active management of third stage of labour). Twenty cases were omitted since they were not fulfilled the eligibility criteria and only three hundred women were completed the study. They were divided into two groups:
Group1 (case group): 100 pregnant women, whom they received carbetocin for the prevention of PPH.
Group 2 (control group): 200 pregnant women, whom they received oxytocin for the prevention of PPH.
Additional information including age, parity, past medical history, and body mass index (BMI) were taken.
Intervention:
The following steps were followed:
- Hemoglobin and hematocrit were assessed before caesarean section.
- One ml of either carbitocin (100 mcg) or oxytocin (10 IU) was given as a bolus intravenous injection by the anesthesiologist after labor of the baby at once.
- The placentae were delivered by controlled cord traction.
- It was the operating obstetrician decision to evaluated the uterine tone, bleeding intra-operatively and the need for an additional uterotonic and method of its administration, dose and duration.
- Our center usual regimen for uterine atony is an oxytocin (40 IU in 500 ml isotonic crystalloid solution) intravenous infusion over 4-5 hours.
Follow up:
For 24 hours was done, that is include:
- Evaluation of blood loss by the obstetrician and the anesthesiologist after skin closure, that is include the entire amount that had been suctioned, taken by the surgical gauzes or spilled in the surgical field, using visual estimation chart for assessment of blood loss.
- The need of any additional uterotonic drugs after the operation was recorded.
- The need of blood transfusion post delivery.
- The blood pressure and pulse rate of the women involved in the study were documented at 0, 5, 10, 20, 30 and 60 minutes after the injection of the drug.
- The period of operation (skin cut into the final closure of the skin) was recorded.
- Intravenous fluid infusion was administered regularly and as it had been stated by the obstetricians and maintained after the operation until oral intake was started.
- Hemoglobin and hematocrit was assessed the day after the caesarean section.
Statistical analysis:
Statistical Package for Social Sciences (SPSS) version 21 was used. Descriptive statistics presented as (mean ± standard deviation) and frequencies as percentages. The database was examined for errors using range and logical data cleaning methods, and inconsistencies were remedied. Chi square test was used to compare between categorical variables (Fishers exact test used when expected variable was less than 20% of total) and t-test was used to compare between two means. Cohen's d, a standardized measure of effect size for difference between 2 means, which can be compared across different variables and studies, since it has no unit of measurement was used. Significance level was set at P < 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Carbetocin | Experimental | Drug: CarbetocinOne ml of Carbitocin (100 mcg), was given as a bolus intravenous injection after labor of the baby at once. |
| Oxytocin | Active comparator | Drug: OxytocinOne ml of Oxytocin (10 IU), was given as a bolus intravenous injection after labor of the baby at once. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients age ≥18 years
- Singleton pregnancy
- Full term gestation
- Emergency cesarean section during labor
Key exclusion criteria (7 listed)
- Cases of coagulopathy
- Drug hypersensitivity
- Medical diseases as; cardiac, hypertension, liver, renal or endocrine diseases
- Uterine fibroids
- Suspected placental pathology (accreta, previa or abruptio)
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: BABALHeat stable Carbetocin, a clear colourless solution. Oxytocic activity: approximately 50 IU of oxytocin/vial. One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection, slowly over 1 minute after labor of the baby at once. It was used once and no further doses were given. Drug was kept in cold storage (2 to 8°C). | Drug | Carbetocin |
| OxytocinAlso: PitocinOxytocin, a clear colourless solution. One ml of oxytocin (10 IU), was given as a bolus intravenous injection over 1 minute, after labor of the baby at once. Further doses can be given accordingly. Drug was kept in cold storage (2 to 8°C). | Drug | Oxytocin |
Primary outcome
Blood loss equal or more than 1000 ml
Time frame: During the first 24 hours
Proportion of women with blood loss equal or more than 1000 ml in both study groups
Use of additional uterotonics
Time frame: During the first 24 hours
Proportion of the women whom they need additional uterotonic agents
3 secondary outcomes
Blood pressure changes in carbetocin versus oxytocin group
Time frame: Within one hour after administration of the drugs
Pulse rate changes in carbetocin versus oxytocin group
Time frame: Within one hour after administration of the drugs
Blood transfusion need
Time frame: During the first 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 28 Nov 2018.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the main outcomes' result reported in this article will be shared.
Related trials for Postpartum Hemorrhage (Primary)
Active, not recruitingObservational study
Intact Cord Placental Delivery vs Delayed Cord Clamping
Intact Cord Placental Delivery, Delayed Cord Clamping
Recruiting
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Postpartum Hemorrhage (Primary)
RecruitingPhase 3
EVE TRIAL , ALMA SYSTAM
Postpartum Haemorrhage (PPH), PPH
Not yet recruiting
Prophylactic Regimen of Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative for Primary Prevention of Postpartum Hemorrhage in Intrapartum Cesarean Section Versus Intravenous Carbetocin Alone
Post Partum Hemorrhage
Recruiting
Effect of Extracellular Calcium on Carbetocin Mediated Contractility in Human Myometrium
Postpartum Hemorrhage (Primary)
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.
Taghreed K Alhaidari, CABOG study chair
Al Kindy College of Medicine, University of Baghdad
Shayma S Al-Zubaidy, FICOG, MD principal investigator
Al- Elweyia Maternity Teaching Hospital
Alaa A Hussein, FICOG, MD principal investigator
Al- Elweyia Maternity Teaching Hospital
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 Oxytocin in people with Postpartum Hemorrhage (Primary), run by Al-Kindy College of Medicine at 1 site in Iraq.
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 4 inclusion and 7 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 28 Nov 2018. 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 Iraq. 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?
Blood loss equal or more than 1000 ml (time frame: During the first 24 hours). 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 28 Nov 2018.