Postpartum HemorrhagePhase 4NCT02391636
Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage
A Phase 4 study testing Carbetocin and Oxytocin in people with Postpartum Hemorrhage, run by Ghamra Military Hospital at 1 site in Egypt.
Trial summary
Double blinded randomized controlled study Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- 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
- 264 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2015to Dec 2016
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Multiple pregnancy
- Presence of uterine fibroid
- Previous Myomectomy
- Presence of placenta previa
- Past History of PPH
- Fetal Macrosomia
- Polyhydramnios
Who cannot join
- Hypertension
- Preeclampsia
- Cardiac, Renal, Liver diseases
- Epilepsy
- History of hypersensitivity to Carbetocin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage: A Randomized Controlled Trial
Double blinded randomized controlled study
Read the detailed description
Women will be randomized into two groups using COMPUTER-GENERATED RANDOM NUMBER LIST.
264 dark colored envelops will be serially numbered containing the corresponding letter of the corresponding drug that will be used.
Group C: 132 women in the carbetocin group will receive a bolus of 100 μg intravenous injection at delivery of the anterior shoulder.
Group O: 132 women in the oxytocin group will receive 5 IU of oxytocin by slow intravenous injection at delivery of the anterior shoulder.
- All patients will receive general anaesthesia.
- Operation will be carried out by a three year registrar (at least).
- Uterus will be repaired in situ. Primary endpoint: is the amount of blood loss.
- Blood loss will be estimated using the change in Hb% and hematocrit, the actual blood loss will be calculated using the following equation:
- The actual blood loss equals the estimated blood volume X difference between the initial hematocrit and the final hematocrit / the initial hematocrit
Secondary endpoints include:
- The need for additional uterotonic medication after carbetocin or oxytocin administration.
- Uterine tone and Uterine fundus level (with respect to the umbilical point, UP) will be monitored during CS, at the end of CS, 2 hours, 12 hours and 24 hours after delivery
- Additional uterotonic drugs, needed if sufficient uterine tone is not achieved within 5 minutes of oxytocin or carbetocin administration, will include: i. Ergometrine 0.5 mg by slow intravenous injection. ii. Misopristol 1000 micrograms rectally.
- The need for blood transfusion or operative interventions related to PPH
- The need for blood transfusion or operative intervention (B-Lynch sutures, uterine artery ligation, internal iliac artery ligation, Hysterectomy) will be considered.
- The change in hemoglobin and hematocrit post versus pre CS
- The drop in hemoglobin level and hematocrit will be evaluated by comparing the hemoglobin concentration on admission and 24 hours after delivery.
- The hemodynamic adverse effects and the cost-benefit of both drugs.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Carbetocin, Oxytocin
- Keywords
- Postpartum Hemorrhage, carbetocin, oxytocin
- 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
at delivery of anterior shoulder
OxytocinDrug
Also called Syntocinon
at delivery of anterior shoulder
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin arm | Experimental | 100 μg intravenous injection at delivery of the anterior shoulder Receives: Drug: Carbetocin |
| oxytocin arm | Active comparator | 5 IU intravenous injection at delivery of the anterior shoulder Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of blood loss
Measured: 24 hours
Secondary outcomes (2)
need for another uterotonic medication
after administration of Carbetocin or Oxytocin
Measured: 5 minutes
need for blood transfusion or operative intervention
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2016
- Study completionDec 2016
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.
- 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, Care provider
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ghamra Military Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams Maternity Hospital
- Responsible party
- Principal investigator, Maged El.Sherif, Ghamra Military Hospital
- Investigators
- Maged M El.Sherif, Principal investigator, Ghamra Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391636
- Sponsor's protocol ID
- 1
- Status last verified
- Jan 2017
- First submitted
- 17 Feb 2015
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02391636
- Acronym / sponsor ID
- 1
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum Hemorrhage, carbetocin, oxytocin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Ghamra Military HospitalUniversity, hospital or other
- Collaborators
- Ain Shams Maternity Hospital
- Study start
- Feb 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Mar 2015 (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.
Double blinded randomized controlled study
Detailed description
Women will be randomized into two groups using COMPUTER-GENERATED RANDOM NUMBER LIST.
264 dark colored envelops will be serially numbered containing the corresponding letter of the corresponding drug that will be used.
Group C: 132 women in the carbetocin group will receive a bolus of 100 μg intravenous injection at delivery of the anterior shoulder.
Group O: 132 women in the oxytocin group will receive 5 IU of oxytocin by slow intravenous injection at delivery of the anterior shoulder.
- All patients will receive general anaesthesia.
- Operation will be carried out by a three year registrar (at least).
- Uterus will be repaired in situ. Primary endpoint: is the amount of blood loss.
- Blood loss will be estimated using the change in Hb% and hematocrit, the actual blood loss will be calculated using the following equation:
- The actual blood loss equals the estimated blood volume X difference between the initial hematocrit and the final hematocrit / the initial hematocrit
Secondary endpoints include:
- The need for additional uterotonic medication after carbetocin or oxytocin administration.
- Uterine tone and Uterine fundus level (with respect to the umbilical point, UP) will be monitored during CS, at the end of CS, 2 hours, 12 hours and 24 hours after delivery
- Additional uterotonic drugs, needed if sufficient uterine tone is not achieved within 5 minutes of oxytocin or carbetocin administration, will include: i. Ergometrine 0.5 mg by slow intravenous injection. ii. Misopristol 1000 micrograms rectally.
- The need for blood transfusion or operative interventions related to PPH
- The need for blood transfusion or operative intervention (B-Lynch sutures, uterine artery ligation, internal iliac artery ligation, Hysterectomy) will be considered.
- The change in hemoglobin and hematocrit post versus pre CS
- The drop in hemoglobin level and hematocrit will be evaluated by comparing the hemoglobin concentration on admission and 24 hours after delivery.
- The hemodynamic adverse effects and the cost-benefit of both drugs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbetocin arm | Experimental | Drug: Carbetocin100 μg intravenous injection at delivery of the anterior shoulder |
| oxytocin arm | Active comparator | Drug: Oxytocin5 IU intravenous injection at delivery of the anterior shoulder |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Multiple pregnancy
- Presence of uterine fibroid
- Previous Myomectomy
- Presence of placenta previa
- Past History of PPH
Key exclusion criteria (5 listed)
- Hypertension
- Preeclampsia
- Cardiac, Renal, Liver diseases
- Epilepsy
- History of hypersensitivity to Carbetocin
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: Pabalat delivery of anterior shoulder | Drug | Carbetocin arm |
| OxytocinAlso: Syntocinonat delivery of anterior shoulder | Drug | oxytocin arm |
Primary outcome
amount of blood loss
Time frame: 24 hours
2 secondary outcomes
need for another uterotonic medication
Time frame: 5 minutes
need for blood transfusion or operative intervention
Time frame: during surgery
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 25 Jan 2017.
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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.
Maged M El.Sherif principal investigator
Ghamra Military 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, run by Ghamra Military Hospital 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 7 inclusion and 5 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 25 Jan 2017. 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?
amount of blood loss (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 25 Jan 2017.