Blood Loss, SurgicalPhase 4NCT05664659
Efficacy of Carbetocin Versus Oxytocin Plus Misoprostol in Decreasing Blood Loss During Cesarean Section
A Phase 4 study testing Oxytocin + misoprostol and Carbetocin in people with Blood Loss, Surgical and Intrapartum Hemorrhage, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The aim of this clinical trial is to test if carbetocin is as effective as oxytocin plus misoprostol in decreasing intraoperative blood loss in women undergoing planned cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Blood Loss, Surgical, Intrapartum Hemorrhage
- What is being tested?
- Oxytocin + misoprostol and Carbetocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2022to 20 May 2023
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women planning to deliver by CS.
- Age between 18-40.
- Gestational age: (36-42 weeks).
Who cannot join
- Women in active labour.
- Rupture of membranes more than 24 hours \&/or intraamniotic infection.
- Suspected extensive adhesions eg: more than P3CS, endometriosis, previous pelvic surgery.
- Antepartum hemorrhage and abnormal placentation e.g.: low lying placenta, placenta previa, placenta accreta.
- Major intrapartum hemorrhage more than 1000 ml.
- History of postpartum hemorrhage.
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- Anemia (Hb level less than 10g/dl).
- Uterine overdistention eg: polyhydramnios, macrosomic baby, multiple pregnancy.
- Known allergy to any of misoprostol, oxytocin, carbetocin.
- Known medical disorders: Diabetes Mellitus, hypertensive disorders, Systemic Lupus Erythematosus.
- Known coagulopathy problem.
- Contraindication \&/or refusal to spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carbetocin Versus Oxytocin Plus Misoprostol in Decreasing Intraoperative Blood Loss in Women Undergoing Planned Cesarean Section
The aim of this clinical trial is to test if carbetocin is as effective as oxytocin plus misoprostol in decreasing intraoperative blood loss in women undergoing planned cesarean section.
The main question it aims to answer is:
- Is carbetocin as effective as oxytocin plus misoprostol in decreasing intraoperative blood loss in women undergoing planned cesarean section?
Researchers will compare 2 groups:
- women receiving Oxytocin plus Misoprostol;
- women receiving Carbetocin as regards:
- estimated blood loss
Read the detailed description
- Type of Study: A randomized controlled clinical trial.
- Study Setting: This study will be conducted in Ain Shams University Maternity Hospital (ASUMH).
- Study duration: 6 months.
- Study population: Women will be recruited from outpatient antenatal clinic of ASUMH.
Sample Size:
104 patients will be enrolled in this study and will be divided into two groups:
- Group A: 52 patients will receive+ Oxytocin (20 IU IV infusion on 1000 ml of normal saline solution) plus misoprostol (600 micrograms rectal). ( The control group )
- Group B: 52 patients will receive 100 micrograms Carbetocin IV slowly. Sample size justification By using PASS 11 software for sample size calculation, setting power at 80%, alpha error at 5% and after reviewing previous study results showed that the haemoglobin level (g/dl) postoperative to caesarean section was higher among women took Carbetocin than those took misoprostol (10.13 ± 0.76 versus 9.57 ± 0.95 respectively); based on that, a sample size of at least 90 pregnant females undergoing elective caesarean section divided randomly into 2 intervention groups [Carbetocin and misoprostol with oxytocin] (45 patients in each group) will be sufficient to achieve study objective, yet the drop out rate 17% so 7 patients will be added in each group.
Procedures:
- Approval of the protocol by the ethical committee of the department of Obstetrics \& Gynecology, Faculty of Medicine, Ain Shams University.
- Recruitment of patients planning to undergo elective cesarean section in ASUMH from antenatal clinic.
- An informed written consent will be taken from all participants before enrollment in the study and after explaining the purpose, possible risks and complications.
- All participants will be subjected to thorough history taking, general and abdominal examination, obstetric ultrasound examination and laboratory investigations including complete blood count to identify eligible patients.
- The expert consultant will take the decision to do the cesarean section.
- Eligible patients will be randomised \& allocated into 2 groups (A) \& (B). Randomization will be done using computer generated list.
- Allocation \& concealment will be done using sealed envelopes prepared according to computer generated list into ratio 1:1. Patients will deliver by cesarean section. Patients in group A will receive 600 micrograms misoprostol rectally immediately before sterilization plus 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution immediately after delivery of the fetus.
- Patients in group B will receive 100ug Carbetocin by slow IV infusion (over one minute) intra-operative immediately after delivery of the fetus.
- Estimation of blood loss will be calculated by :
- After delivery of the placenta, the amount of blood loss in the suction canister and drapes will be measured.
- The equation* used when calculating blood loss of a blood-soaked item is WET Item Gram Weight - DRY Item Gram Weight=Milliliters of Blood Within the Item. The items are weighed using a highly accurate digital balance ( Salter digital electronic scale 9037 TL3R).
- Although a gram is a unit of mass and a milliliter is a unit of volume, the conversion from one to the other is a simple 1-to-1 conversion.
- The amniotic fluid index (AFI) was estimated using abdominal ultrasound as the sum of the maximum vertical diameter of amniotic fluid in four quadrants in centimeters.
- Amniotic fluid volume (AFV) (ml) was estimated by multiplying AFI (cm) by 30.
- At the end of the surgery, the volume of quantified blood calculated by weight will be added to the volume of quantified blood in the suction canister then subtracting the amniotic fluid volume to determine total quantification of blood loss.
- Follow up \& data recording; • Post-partum hemorrhage will be considered:
- Minor PPH: if estimated blood loss from 500 ml to 1000 ml. 2. Major PPH: if any estimated blood loss is more than 1000 ml.
- Measuring hemoglobin level before \& after 24 hours of delivery to asses the need for blood transfusion.
- All data will be recorded in Case Report Form.
- Conditions
- Blood Loss, Surgical, Intrapartum Hemorrhage
- Being tested
- Oxytocin + misoprostol, Carbetocin
- Keywords
- estimated blood loss, carbetocin, oxytocin, misoprostol
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin + misoprostolDrug
600 micrograms misoprostol rectally 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution
CarbetocinDrug
100 micrograms carbetocin
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin+Misoprostol | Active comparator | Patients in this group will receive 600 micrograms misoprostol rectally immediately before sterilization plus 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution immediately after delivery of the fetus. Receives: Drug: Oxytocin + misoprostol |
| Carbetocin | Experimental | Patients in this group will receive 100ug Carbetocin by slow IV infusion (over one minute) intra-operative immediately after delivery of the fetus. Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimated blood loss in millimeters
estimated blood lost during the cesarean section (CS)
Measured: calculated once at the end of the CS
Secondary outcomes (1)
drop in hemoglobin
Difference in Hemoglobin level before and after CS
Measured: calculated once after 24hours of the CS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start20 Dec 2022
- Primary completion30 Apr 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies 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, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Hassan Mostafa, Ain Shams Maternity Hospital
- Investigators
- Mohamed SE Sweed, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664659
- Sponsor's protocol ID
- FMASU MS 211/2022
- Status last verified
- Jul 2023
- First submitted
- 16 Dec 2022
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and the analytic code will be made available from the central contact on reasonable requests
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin Versus Oxytocin Plus Misoprostol in Decreasing Intraoperative Blood Loss in Women Undergoing Planned Cesarean Section
- ClinicalTrials.gov ID
- NCT05664659
- Acronym / sponsor ID
- FMASU MS 211/2022
- Conditions
- Blood Loss, Surgical, Intrapartum Hemorrhage
- Keywords
- estimated blood loss, carbetocin, oxytocin, misoprostol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 27 Dec 2022 (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.
The aim of this clinical trial is to test if carbetocin is as effective as oxytocin plus misoprostol in decreasing intraoperative blood loss in women undergoing planned cesarean section.
The main question it aims to answer is:
- Is carbetocin as effective as oxytocin plus misoprostol in decreasing intraoperative blood loss in women undergoing planned cesarean section?
Researchers will compare 2 groups:
- women receiving Oxytocin plus Misoprostol;
- women receiving Carbetocin as regards:
- estimated blood loss
Detailed description
- Type of Study: A randomized controlled clinical trial.
- Study Setting: This study will be conducted in Ain Shams University Maternity Hospital (ASUMH).
- Study duration: 6 months.
- Study population: Women will be recruited from outpatient antenatal clinic of ASUMH.
Sample Size:
104 patients will be enrolled in this study and will be divided into two groups:
- Group A: 52 patients will receive+ Oxytocin (20 IU IV infusion on 1000 ml of normal saline solution) plus misoprostol (600 micrograms rectal). ( The control group )
- Group B: 52 patients will receive 100 micrograms Carbetocin IV slowly. Sample size justification By using PASS 11 software for sample size calculation, setting power at 80%, alpha error at 5% and after reviewing previous study results showed that the haemoglobin level (g/dl) postoperative to caesarean section was higher among women took Carbetocin than those took misoprostol (10.13 ± 0.76 versus 9.57 ± 0.95 respectively); based on that, a sample size of at least 90 pregnant females undergoing elective caesarean section divided randomly into 2 intervention groups [Carbetocin and misoprostol with oxytocin] (45 patients in each group) will be sufficient to achieve study objective, yet the drop out rate 17% so 7 patients will be added in each group.
Procedures:
- Approval of the protocol by the ethical committee of the department of Obstetrics \& Gynecology, Faculty of Medicine, Ain Shams University.
- Recruitment of patients planning to undergo elective cesarean section in ASUMH from antenatal clinic.
- An informed written consent will be taken from all participants before enrollment in the study and after explaining the purpose, possible risks and complications.
- All participants will be subjected to thorough history taking, general and abdominal examination, obstetric ultrasound examination and laboratory investigations including complete blood count to identify eligible patients.
- The expert consultant will take the decision to do the cesarean section.
- Eligible patients will be randomised \& allocated into 2 groups (A) \& (B). Randomization will be done using computer generated list.
- Allocation \& concealment will be done using sealed envelopes prepared according to computer generated list into ratio 1:1. Patients will deliver by cesarean section. Patients in group A will receive 600 micrograms misoprostol rectally immediately before sterilization plus 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution immediately after delivery of the fetus.
- Patients in group B will receive 100ug Carbetocin by slow IV infusion (over one minute) intra-operative immediately after delivery of the fetus.
- Estimation of blood loss will be calculated by :
- After delivery of the placenta, the amount of blood loss in the suction canister and drapes will be measured.
- The equation* used when calculating blood loss of a blood-soaked item is WET Item Gram Weight - DRY Item Gram Weight=Milliliters of Blood Within the Item. The items are weighed using a highly accurate digital balance ( Salter digital electronic scale 9037 TL3R).
- Although a gram is a unit of mass and a milliliter is a unit of volume, the conversion from one to the other is a simple 1-to-1 conversion.
- The amniotic fluid index (AFI) was estimated using abdominal ultrasound as the sum of the maximum vertical diameter of amniotic fluid in four quadrants in centimeters.
- Amniotic fluid volume (AFV) (ml) was estimated by multiplying AFI (cm) by 30.
- At the end of the surgery, the volume of quantified blood calculated by weight will be added to the volume of quantified blood in the suction canister then subtracting the amniotic fluid volume to determine total quantification of blood loss.
- Follow up \& data recording; • Post-partum hemorrhage will be considered:
- Minor PPH: if estimated blood loss from 500 ml to 1000 ml. 2. Major PPH: if any estimated blood loss is more than 1000 ml.
- Measuring hemoglobin level before \& after 24 hours of delivery to asses the need for blood transfusion.
- All data will be recorded in Case Report Form.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin+Misoprostol | Active comparator | Drug: Oxytocin + misoprostolPatients in this group will receive 600 micrograms misoprostol rectally immediately before sterilization plus 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution immediately after delivery of the fetus. |
| Carbetocin | Experimental | Drug: CarbetocinPatients in this group will receive 100ug Carbetocin by slow IV infusion (over one minute) intra-operative immediately after delivery of the fetus. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women planning to deliver by CS.
- Age between 18-40.
- Gestational age: (36-42 weeks).
Key exclusion criteria (12 listed)
- Women in active labour.
- Rupture of membranes more than 24 hours \&/or intraamniotic infection.
- Suspected extensive adhesions eg: more than P3CS, endometriosis, previous pelvic surgery.
- Antepartum hemorrhage and abnormal placentation e.g.: low lying placenta, placenta previa, placenta accreta.
- Major intrapartum hemorrhage more than 1000 ml.
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 |
|---|---|---|
| Oxytocin + misoprostol600 micrograms misoprostol rectally 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution | Drug | Oxytocin+Misoprostol |
| Carbetocin100 micrograms carbetocin | Drug | Carbetocin |
Primary outcome
estimated blood loss in millimeters
Time frame: calculated once at the end of the CS
estimated blood lost during the cesarean section (CS)
1 secondary outcome
drop in hemoglobin
Time frame: calculated once after 24hours of the CS
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 Jul 2023.
- Individual participant dataSharing planned: Yes. The study protocol and the analytic code will be made available from the central contact on reasonable requests
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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.
Mohamed SE Sweed, MD study director
Ain Shams 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 Oxytocin + misoprostol and Carbetocin in people with Blood Loss, Surgical and Intrapartum Hemorrhage, run by Ain Shams Maternity 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 3 inclusion and 12 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 Jul 2023. 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?
estimated blood loss in millimeters (time frame: calculated once at the end of the CS). 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 Jul 2023.