Postpartum HemorrhagePhase 4CARBOXY-RCTNCT07636421
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
A Phase 4 study testing Carbetocin and Oxytocin in people with Postpartum Hemorrhage and Uterine Atony, run by Mansoura University at 1 site in Saudi Arabia.
Trial summary
Background: Carbetocin is an established single-dose uterotonic agent for postpartum hemorrhage prophylaxis at elective cesarean delivery. Despite its proven efficacy, many clinicians routinely add a supplemental oxytocin infusion following carbetocin administration without evidence-based justification. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Hemorrhage, Uterine Atony, Cesarean Section
- What is being tested?
- Carbetocin and Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 8 Aug 2026to Aug 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult women aged 18 to 45 years
- Scheduled for elective non-emergency cesarean delivery
- Spinal anesthesia planned and administered as the sole anesthetic technique
- Singleton pregnancy at gestational age of 37 completed weeks or more
- ASA physical status II
- Preoperative hemoglobin of 9 g/dL or more
- Able to provide written informed consent in Arabic or English
Who cannot join
- Emergency or crash cesarean delivery
- Placenta previa, placenta accreta spectrum disorder, or other abnormal placentation
- Known uterine anomalies likely to impair contractility including fibroids greater than 5 cm, bicornuate or unicornuate uterus
- Grand multiparity defined as 5 or more previous deliveries
- Multiple gestation including twins or higher order
- Polyhydramnios defined as amniotic fluid index greater than 24 cm
Show all 14Show fewer
- Prior oxytocin augmentation in current pregnancy for more than 6 hours
- Known hypersensitivity to carbetocin, oxytocin, or any formulation excipient
- Severe preeclampsia, eclampsia, or HELLP syndrome
- Cardiovascular disease including arrhythmia, valvular disease, cardiomyopathy, or ischemic heart disease
- Known coagulopathy or thrombocytopenia with platelets less than 100 x 10^9/L
- Hepatic or renal impairment
- Body mass index greater than 40 kg/m2 at time of delivery
- Enrollment in another interventional clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Qassim University Medical City
Buraidah, Al-Qassim Region, 51452
Mohamed A Tolba, MD, 966507439018, m_atolba1234@mans.edu.eg
Omar S Al Misnid, MD, 966561205555, OMisnid@qumc.edu.sa
About this study
Official title: Comparative Efficacy of Carbetocin Monotherapy Versus Carbetocin With Supplemental Oxytocin Infusion in Maintaining Uterine Tone and Preventing Blood Loss in Elective Cesarean Delivery: A Randomized, Double-Blind, Non-Inferiority Controlled Trial
Background: Carbetocin is an established single-dose uterotonic agent for postpartum hemorrhage prophylaxis at elective cesarean delivery. Despite its proven efficacy, many clinicians routinely add a supplemental oxytocin infusion following carbetocin administration without evidence-based justification. Concurrent oxytocin receptor stimulation may be redundant, counterproductive through receptor desensitization, or incrementally beneficial - a mechanistic uncertainty that remains unresolved in the published literature.
Objectives: To determine whether carbetocin monotherapy (100 micrograms IV bolus plus placebo infusion) is non-inferior to carbetocin plus supplemental oxytocin infusion (10 IU over 4 hours) in preventing the need for additional uterotonic agents within 24 hours of elective cesarean delivery.
Read more
Study Design: Prospective, randomized, double-blind, placebo-controlled, non-inferiority trial with an integrated pilot phase. Phase 1 (Pilot, n=60) establishes local feasibility and event rate. Phase 2 (Full trial, n=332) provides the definitive non-inferiority analysis.
Participants: Women aged 18-45 years undergoing elective cesarean delivery under spinal anesthesia at Qassim University Medical City, singleton pregnancy at or beyond 37 weeks, ASA physical status II, preoperative hemoglobin 9 g/dL or more.
Interventions: Group C (Monotherapy): Carbetocin 100 micrograms IV bolus plus placebo saline infusion 500 mL over 4 hours. Group C+O (Combination): Carbetocin 100 micrograms IV bolus plus oxytocin 10 IU in 500 mL saline over 4 hours.
Primary Outcome: Proportion of patients requiring at least one additional uterotonic agent within 24 hours of delivery.
Secondary Outcomes: Quantitative intraoperative blood loss by gravimetric measurement; total 24-hour blood loss; actual blood loss by Gross formula; hemoglobin and hematocrit changes; uterine tone scores by verbal numerical rating scale (0-10) at 2, 5, and 10 minutes; incidence of postpartum hemorrhage; blood transfusion requirement; hemodynamic profiles; adverse effects.
Sample Size: 332 patients (166 per group), non-inferiority margin 10 percentage points, one-sided alpha 0.025, 80% power, estimated baseline event rate 10%, with 15% dropout allowance.
Read the detailed description
PHARMACOLOGICAL RATIONALE:
Carbetocin exerts its uterotonic effect through sustained occupancy of myometrial oxytocin receptors (OTRs). Continuous stimulation of OTRs triggers homologous receptor desensitization, progressively reducing myometrial responsiveness. The addition of an oxytocin infusion following carbetocin raises three competing hypotheses: (1) incremental benefit from residual unoccupied receptors; (2) receptor counterproductivity through accelerated downregulation; or (3) pharmacological redundancy. No published RCT has resolved this uncertainty.
TRIAL DESIGN:
The trial uses a non-inferiority design because the combination regimen is already practiced without evidence. Demonstrating non-inferiority of monotherapy would provide the first evidence to safely simplify uterotonic regimens, reduce drug costs, nursing workload, and unnecessary receptor stimulation.
BLOOD LOSS MEASUREMENT:
Intraoperative blood loss measured by gravimetric quantification: [Weight soaked materials minus Weight dry materials] divided by 1.05, plus suction canister volume, minus irrigation volume, minus amniotic fluid volume. Secondary measurement uses the Gross formula: ABL = EBV x (Hb preoperative minus Hb postoperative) divided by Hb preoperative, where EBV = body weight (kg) x 85 mL/kg.
UTERINE TONE ASSESSMENT:
Assessed using the 11-point Verbal Numerical Rating Scale (VNRS 0-10) with predefined anchor definitions, by the blinded operating obstetrician via bimanual palpation at 2, 5, and 10 minutes following carbetocin bolus. Pre-study inter-rater calibration session with intraclass correlation coefficient target of 0.80 or more.
STANDARDIZED FLUID PROTOCOL:
All patients receive a standardized intravenous fluid protocol to eliminate hemodilution as a confounding variable: spinal coload Ringer's Lactate 500 mL; intraoperative maintenance 100 mL/hour; study infusion 500 mL over 4 hours identical in both groups; postoperative Ringer's Lactate 80 mL/hour for 8 hours. Total 24-hour fluid volume recorded as a statistical covariate.
STATISTICAL ANALYSIS:
Non-inferiority declared if the upper bound of the two-sided 95% confidence interval of the risk difference does not exceed +0.10. Both per-protocol and intention-to-treat analyses performed; concordance of both required per ICH E9(R1). IRB approval: Subcommittee of Health and Bioethics Research Ethics, Qassim University, Approval No. 26-23-4, dated June 02, 2026.
- Being tested
- Carbetocin, Oxytocin, Placebo Saline Infusion
- Keywords
- Carbetocin, Oxytocin, Uterotonic, Elective Cesarean Delivery, Non-Inferiority Trial, Uterine Tone, Gravimetric Blood Loss, Obstetric Anesthesia, Spinal Anesthesia
- Medical subject headings
- Postpartum Hemorrhage, Uterine Inertia, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Also called Duratocin, Pabal
Carbetocin 100 micrograms (1 mL) IV bolus administered over 1 minute immediately after umbilical cord clamping. Identical administration in both arms.
OxytocinDrug
Also called Syntocinon
Oxytocin 10 IU added to 500 mL 0.9% sodium chloride, infused at 83 mL/hour over 4 hours, initiated within 2 minutes of carbetocin bolus. Administered in the combination arm only.
Placebo Saline InfusionDrug
Also called Normal Saline Placebo
500 mL 0.9% sodium chloride infused at 83 mL/hour over 4 hours, initiated within 2 minutes of carbetocin bolus. Visually identical to the active oxytocin infusion. Administered in the monotherapy arm only.
| Study group | Role | What they receive |
|---|---|---|
| Group C - Carbetocin Monotherapy | Active comparator | Carbetocin 100 micrograms IV bolus over 1 minute immediately after cord clamping, followed by placebo infusion (500 mL 0.9% sodium chloride at 83 mL/hour over 4 hours). The infusion bag is visually identical to the active arm. Receives: Drug: Carbetocin; Drug: Placebo Saline Infusion |
| Group C+O - Carbetocin Plus Oxytocin | Experimental | Carbetocin 100 micrograms IV bolus over 1 minute immediately after cord clamping, followed by active infusion (oxytocin 10 IU in 500 mL 0.9% sodium chloride at 83 mL/hour over 4 hours). Receives: Drug: Carbetocin; Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Additional Uterotonic Requirement Within 24 Hours
Proportion of patients requiring at least one additional rescue uterotonic agent at any timepoint within 24 hours of delivery, based on clinical assessment of inadequate uterine tone or uterine atony by the attending obstetrician or anesthesiologist.
Measured: Within 24 hours of delivery
Secondary outcomes (11)
Intraoperative Blood Loss - Gravimetric Method
Quantitative intraoperative blood loss measured by gravimetric method: weight of soaked materials minus dry materials divided by 1.05, plus suction volume, minus irrigation and amniotic fluid volumes.
Measured: Intraoperative - from cord clamping to skin closure
Total 24-Hour Blood Loss
Cumulative blood loss combining gravimetric intraoperative measurement and weighed postoperative lochia pads at 2 and 24 hours.
Measured: 0 to 24 hours after delivery
Actual Blood Loss - Gross Formula
Calculated using estimated blood volume multiplied by the ratio of preoperative to postoperative hemoglobin change: ABL = EBV x (Hb preoperative minus Hb postoperative) divided by Hb preoperative, where EBV = body weight in kg x 85 mL/kg.
Measured: Preoperative baseline to 24 hours postoperatively
Hemoglobin Change
Change in venous hemoglobin concentration from preoperative baseline to 24 hours postoperatively, measured by automated complete blood count analyzer.
Measured: Preoperative baseline to 24 hours postoperatively
Hematocrit Change
Change in hematocrit from preoperative baseline to 24 hours postoperatively, measured by automated complete blood count analyzer.
Measured: Preoperative baseline to 24 hours postoperatively
Uterine Tone Score - Verbal Numerical Rating Scale
Uterine tone assessed by blinded obstetrician using 11-point Verbal Numerical Rating Scale (0 = completely atonic, 10 = maximally contracted) via bimanual palpation at three timepoints.
Measured: At 2, 5, and 10 minutes after carbetocin bolus
Postpartum Hemorrhage Incidence
Proportion of patients with total blood loss of 1000 mL or more within 24 hours of delivery, measured by gravimetric quantification.
Measured: Within 24 hours of delivery
Blood Transfusion Requirement
Proportion of patients receiving packed red blood cell transfusion and total units of packed red blood cells transfused.
Measured: Within 24 hours of delivery
Systolic Blood Pressure
Systolic blood pressure measured by non-invasive blood pressure cuff monitoring intraoperatively and in the postanesthesia care unit.
Measured: Every 2.5 minutes intraoperatively and every 15 minutes for 4 hours postoperatively
Heart Rate
Heart rate measured by continuous 5-lead electrocardiogram monitoring intraoperatively and in the postanesthesia care unit.
Measured: Continuous intraoperatively and every 15 minutes for 4 hours postoperatively
Adverse Effects Incidence
Incidence and severity of drug-related adverse effects including nausea, vomiting, facial flushing, headache, chest tightness, tachycardia, hypotension, and oliguria, documented by standardized checklist.
Measured: Within 24 hours of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start8 Aug 2026
- Primary completionApr 2028 (estimated)
- Study completionAug 2028 (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 Mansoura 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
- Model description
- Two parallel groups with 1:1 randomization. Group C receives carbetocin monotherapy (bolus plus placebo infusion). Group C+O receives carbetocin plus supplemental oxytocin infusion. Block randomization with variable block sizes of 4 and 6, stratified by parity.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Tolba, Mansoura University
- Investigators
- Mohamed A Tolba, MD, Principal investigator, Qassim University Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636421
- Sponsor's protocol ID
- CARBOXY-RCT-001
- Other IDs
- QU-IRB-26-23-4
- Acronym
- CARBOXY-RCT
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for the primary and all secondary outcome measures will be made available upon reasonable request to the principal investigator following publication of the primary results manuscript. Requests will be reviewed and approved based on scientific merit and ethical appropriateness. Requestors will be required to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Carbetocin Monotherapy Versus Carbetocin With Supplemental Oxytocin Infusion in Maintaining Uterine Tone and Preventing Blood Loss in Elective Cesarean Delivery: A Randomized, Double-Blind, Non-Inferiority Controlled Trial
- ClinicalTrials.gov ID
- NCT07636421
- Acronym / sponsor ID
- CARBOXY-RCT / CARBOXY-RCT-001
- Keywords
- Carbetocin, Oxytocin, Uterotonic, Elective Cesarean Delivery, Non-Inferiority Trial, Uterine Tone, Gravimetric Blood Loss, Obstetric Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 8 Aug 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 9 Jun 2026 (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.
Background: Carbetocin is an established single-dose uterotonic agent for postpartum hemorrhage prophylaxis at elective cesarean delivery. Despite its proven efficacy, many clinicians routinely add a supplemental oxytocin infusion following carbetocin administration without evidence-based justification. Concurrent oxytocin receptor stimulation may be redundant, counterproductive through receptor desensitization, or incrementally beneficial - a mechanistic uncertainty that remains unresolved in the published literature.
Objectives: To determine whether carbetocin monotherapy (100 micrograms IV bolus plus placebo infusion) is non-inferior to carbetocin plus supplemental oxytocin infusion (10 IU over 4 hours) in preventing the need for additional uterotonic agents within 24 hours of elective cesarean delivery.
Study Design: Prospective, randomized, double-blind, placebo-controlled, non-inferiority trial with an integrated pilot phase. Phase 1 (Pilot, n=60) establishes local feasibility and event rate. Phase 2 (Full trial, n=332) provides the definitive non-inferiority analysis.
Participants: Women aged 18-45 years undergoing elective cesarean delivery under spinal anesthesia at Qassim University Medical City, singleton pregnancy at or beyond 37 weeks, ASA physical status II, preoperative hemoglobin 9 g/dL or more.
Interventions: Group C (Monotherapy): Carbetocin 100 micrograms IV bolus plus placebo saline infusion 500 mL over 4 hours. Group C+O (Combination): Carbetocin 100 micrograms IV bolus plus oxytocin 10 IU in 500 mL saline over 4 hours.
Primary Outcome: Proportion of patients requiring at least one additional uterotonic agent within 24 hours of delivery.
Secondary Outcomes: Quantitative intraoperative blood loss by gravimetric measurement; total 24-hour blood loss; actual blood loss by Gross formula; hemoglobin and hematocrit changes; uterine tone scores by verbal numerical rating scale (0-10) at 2, 5, and 10 minutes; incidence of postpartum hemorrhage; blood transfusion requirement; hemodynamic profiles; adverse effects.
Sample Size: 332 patients (166 per group), non-inferiority margin 10 percentage points, one-sided alpha 0.025, 80% power, estimated baseline event rate 10%, with 15% dropout allowance.
Detailed description
PHARMACOLOGICAL RATIONALE:
Carbetocin exerts its uterotonic effect through sustained occupancy of myometrial oxytocin receptors (OTRs). Continuous stimulation of OTRs triggers homologous receptor desensitization, progressively reducing myometrial responsiveness. The addition of an oxytocin infusion following carbetocin raises three competing hypotheses: (1) incremental benefit from residual unoccupied receptors; (2) receptor counterproductivity through accelerated downregulation; or (3) pharmacological redundancy. No published RCT has resolved this uncertainty.
TRIAL DESIGN:
The trial uses a non-inferiority design because the combination regimen is already practiced without evidence. Demonstrating non-inferiority of monotherapy would provide the first evidence to safely simplify uterotonic regimens, reduce drug costs, nursing workload, and unnecessary receptor stimulation.
BLOOD LOSS MEASUREMENT:
Intraoperative blood loss measured by gravimetric quantification: [Weight soaked materials minus Weight dry materials] divided by 1.05, plus suction canister volume, minus irrigation volume, minus amniotic fluid volume. Secondary measurement uses the Gross formula: ABL = EBV x (Hb preoperative minus Hb postoperative) divided by Hb preoperative, where EBV = body weight (kg) x 85 mL/kg.
UTERINE TONE ASSESSMENT:
Assessed using the 11-point Verbal Numerical Rating Scale (VNRS 0-10) with predefined anchor definitions, by the blinded operating obstetrician via bimanual palpation at 2, 5, and 10 minutes following carbetocin bolus. Pre-study inter-rater calibration session with intraclass correlation coefficient target of 0.80 or more.
STANDARDIZED FLUID PROTOCOL:
All patients receive a standardized intravenous fluid protocol to eliminate hemodilution as a confounding variable: spinal coload Ringer's Lactate 500 mL; intraoperative maintenance 100 mL/hour; study infusion 500 mL over 4 hours identical in both groups; postoperative Ringer's Lactate 80 mL/hour for 8 hours. Total 24-hour fluid volume recorded as a statistical covariate.
STATISTICAL ANALYSIS:
Non-inferiority declared if the upper bound of the two-sided 95% confidence interval of the risk difference does not exceed +0.10. Both per-protocol and intention-to-treat analyses performed; concordance of both required per ICH E9(R1). IRB approval: Subcommittee of Health and Bioethics Research Ethics, Qassim University, Approval No. 26-23-4, dated June 02, 2026.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups with 1:1 randomization. Group C receives carbetocin monotherapy (bolus plus placebo infusion). Group C+O receives carbetocin plus supplemental oxytocin infusion. Block randomization with variable block sizes of 4 and 6, stratified by parity.
| Arm | Type | Receives |
|---|---|---|
| Group C - Carbetocin Monotherapy | Active comparator | Drug: Carbetocin, Drug: Placebo Saline InfusionCarbetocin 100 micrograms IV bolus over 1 minute immediately after cord clamping, followed by placebo infusion (500 mL 0.9% sodium chloride at 83 mL/hour over 4 hours). The infusion bag is visually identical to the active arm. |
| Group C+O - Carbetocin Plus Oxytocin | Experimental | Drug: Carbetocin, Drug: OxytocinCarbetocin 100 micrograms IV bolus over 1 minute immediately after cord clamping, followed by active infusion (oxytocin 10 IU in 500 mL 0.9% sodium chloride at 83 mL/hour over 4 hours). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult women aged 18 to 45 years
- Scheduled for elective non-emergency cesarean delivery
- Spinal anesthesia planned and administered as the sole anesthetic technique
- Singleton pregnancy at gestational age of 37 completed weeks or more
- ASA physical status II
Key exclusion criteria (14 listed)
- Emergency or crash cesarean delivery
- Placenta previa, placenta accreta spectrum disorder, or other abnormal placentation
- Known uterine anomalies likely to impair contractility including fibroids greater than 5 cm, bicornuate or unicornuate uterus
- Grand multiparity defined as 5 or more previous deliveries
- Multiple gestation including twins or higher order
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: Duratocin, PabalCarbetocin 100 micrograms (1 mL) IV bolus administered over 1 minute immediately after umbilical cord clamping. Identical administration in both arms. | Drug | Group C - Carbetocin Monotherapy, Group C+O - Carbetocin Plus Oxytocin |
| OxytocinAlso: SyntocinonOxytocin 10 IU added to 500 mL 0.9% sodium chloride, infused at 83 mL/hour over 4 hours, initiated within 2 minutes of carbetocin bolus. Administered in the combination arm only. | Drug | Group C+O - Carbetocin Plus Oxytocin |
| Placebo Saline InfusionAlso: Normal Saline Placebo500 mL 0.9% sodium chloride infused at 83 mL/hour over 4 hours, initiated within 2 minutes of carbetocin bolus. Visually identical to the active oxytocin infusion. Administered in the monotherapy arm only. | Drug | Group C - Carbetocin Monotherapy |
Primary outcome
Additional Uterotonic Requirement Within 24 Hours
Time frame: Within 24 hours of delivery
Proportion of patients requiring at least one additional rescue uterotonic agent at any timepoint within 24 hours of delivery, based on clinical assessment of inadequate uterine tone or uterine atony by the attending obstetrician or anesthesiologist.
11 secondary outcomes
Intraoperative Blood Loss - Gravimetric Method
Time frame: Intraoperative - from cord clamping to skin closure
Total 24-Hour Blood Loss
Time frame: 0 to 24 hours after delivery
Actual Blood Loss - Gross Formula
Time frame: Preoperative baseline to 24 hours postoperatively
Hemoglobin Change
Time frame: Preoperative baseline to 24 hours postoperatively
Hematocrit Change
Time frame: Preoperative baseline to 24 hours postoperatively
Uterine Tone Score - Verbal Numerical Rating Scale
Time frame: At 2, 5, and 10 minutes after carbetocin bolus
Postpartum Hemorrhage Incidence
Time frame: Within 24 hours of delivery
Blood Transfusion Requirement
Time frame: Within 24 hours of delivery
Systolic Blood Pressure
Time frame: Every 2.5 minutes intraoperatively and every 15 minutes for 4 hours postoperatively
Heart Rate
Time frame: Continuous intraoperatively and every 15 minutes for 4 hours postoperatively
Adverse Effects Incidence
Time frame: Within 24 hours of delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for the primary and all secondary outcome measures will be made available upon reasonable request to the principal investigator following publication of the primary results manuscript. Requests will be reviewed and approved based on scientific merit and ethical appropriateness. Requestors will be required to sign a data access agreement.
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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.
Mohamed A Tolba, MD principal investigator
Qassim University Medical City
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 and Uterine Atony, run by Mansoura University at 1 site in Saudi Arabia.
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 14 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. 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 Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Tolba, MD (966507439018, m_atolba1234@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Additional Uterotonic Requirement Within 24 Hours (time frame: Within 24 hours of delivery). 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 Oct 2026.