Cesarean SectionNCT06956365
To Compare the Effects of Oxytocin and Carbetocin on Intraoperative Hemodynamic Changes in Cesarean Section Surgeries.
A study testing Group-C and Group-O in people with Cesarean Section, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
To compare the effects of oxytocin and carbetocin, used as uterotonics in elective caesarean section surgeries, in terms of intraoperative hemodynamic changes. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Group-C and Group-O
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2024to 30 Jul 2025
- Phase
- Interventional
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients scheduled for caesarean sections
- Between 18-40 years
- ASA I-II group
- Those who will undergo general anesthesia
- Those between 35-40 weeks of pregnancy
- 1st and 2nd caesarean sections
Who cannot join
- Those who prefer spinal or epidural anesthesia
- Those who are outside the age range of 18-40
- Those who are ASA III and above
- Those with HT, DM, cardiac and respiratory diseases
- Preeclampsia, eclampsia, HELLP
- Those with a history of drug use that affects the cardiovascular system
- Placenta Previa, Placenta Acreta, Placenta Acreta
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Van Yuzuncu Yil University
Van, Tuşba, 65100
Şükran ŞS Sevimli, MD, +90 5445262921, sevimli@hotmail.com
About this study
Official title: Van Yuzuncu Yil University Faculty of Medicine Ethics Committee
To compare the effects of oxytocin and carbetocin, used as uterotonics in elective caesarean section surgeries, in terms of intraoperative hemodynamic changes.
Read the detailed description
The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 80 patients planned for elective caesarean section surgeries , aged 18-40 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 40 patients each.
All cases will receive routine preparation for general anesthesia. All patients placed on the operating room will receive two large-bore vascular access. For anesthesia induction 2 mg/kg propofol and 0.5 mg/kg rocuronium will be used. Anesthesia will be maintained with 60% air, 40% oxygen and 2 MAC sevoflurane.Demographic data of the patients (age, height, weight), ASA score and surgical time will be recorded. During the operation, hemodynamic parameters will be recorded just before the drugs are given and at the 1st, 5th, 10th, 15th, 20th, 25th and 30th minutes after the drug is given. In addition, intraoperative blood loss and the need for additional uterotonics throughout the surgery will be recorded. All data will be recorded and statistical analysis will be made.
- Conditions
- Cesarean Section
- Being tested
- Group-C, Group-O
- Keywords
- Cesarean section, Oxytocin, Carbetocin, Uterotonic, Intraoperative bleeding
- 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.
Group-CProcedure or surgery
Also called Group Carbetosin
100 iu carbetosin administered to carbetocin group
Group-OProcedure or surgery
Also called Group Oxytocine
In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin (Group-O) | Active comparator | Group-O: Oxytocin group (n:40). In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered. Receives: Procedure: Group-O |
| Carbetocin (Group-C) | Experimental | Group-C: Carbetocin group (n:40). In cesarean surgery, 100 μg carbetocin IV bolus will be administered after the baby delivered. Receives: Procedure: Group-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine tonus
The effect of carbetocin on uterine tone will be evaluated by the surgical team using a numerical scoring scale between 0-10. A score of 0 will indicate atony, and a score of 10 will indicate full contraction.
Measured: For 30 minutes after carbetocin administration.
Additional uterotonic drug requirement
If the uterine tone is 7 or below, the surgical team will perform uterine massage, and in patients who do not see a sufficient increase in uterine tone, an additional uterotonic, 0.2 mg methylergonavine (Methyl ampoule 0.2 mg/ml) will be administered IM by the anesthesia team and recorded.
Measured: For 30 minutes after carbetocin administration.
Secondary outcomes (3)
Intraoperative bleeding
Total intraoperative bleeding was recorded by calculating and estimating the aspirator volume, pad-sponge-compress count and surgical area.
Measured: from drug administration to the end of surgery.
Mean Blood Pressure
Mean blood pressure will be measured every 5 minutes intraoperatively using a noninvasive method.
Measured: Intraoperatively every 5 minutes
Heart Rate
Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method.
Measured: Intraoperatively every 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start14 May 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In 80 pregnant patients scheduled for elective cesarean section, patients will be randomly assigned to receive 5 IU oxytocin or 100 μg carbetocin IV bolus intraoperatively after the birth of the baby.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurettin KURT, Yuzuncu Yil University
- Investigators
- Şükran ŞS Sevimli, Assoc.Prof, Study director, Van Yüzüncü Yıl University Van/Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956365
- Sponsor's protocol ID
- 2022/09-10
- Status last verified
- Apr 2025
- First submitted
- 22 Aug 2023
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol anda statistical analysis plan will be share with other researchers
Publications
He G, Li LI, Guan E, Chen J, Qin YI, Xie Y. Fentanyl inhibits the progression of human gastric carcinoma MGC-803 cells by modulating NF-kappaB-dependent gene expression in vivo. Oncol Lett. 2016 Jul;12(1):563-571. doi: 10.3892/ol.2016.4619. Epub 2016 May 25.
PubMed 27347181Dutriez-Casteloot I, Emmanuelli V, Wiart JF, Tavernier A, Besengez C, Storme L, Houfflin-Debarge V. Long-Lasting Analgesia With Transdermal Fentanyl: A New Approach in Rat Neonatal Research. Front Pharmacol. 2022 Mar 17;13:798011. doi: 10.3389/fphar.2022.798011. eCollection 2022.
PubMed 35370716Clemensen J, Rasmussen LV, Abelson KSP. Transdermal Fentanyl Solution Provides Long-term Analgesia in the Hind-paw Incisional Model of Postoperative Pain in Male Rats. In Vivo. 2018 Jul-Aug;32(4):713-719. doi: 10.21873/invivo.11299.
PubMed 29936450
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Van Yuzuncu Yil University Faculty of Medicine Ethics Committee
- ClinicalTrials.gov ID
- NCT06956365
- Acronym / sponsor ID
- 2022/09-10
- Conditions
- Cesarean Section
- Keywords
- Cesarean section, Oxytocin, Carbetocin, Uterotonic, Intraoperative bleeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 4 May 2025 (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.
To compare the effects of oxytocin and carbetocin, used as uterotonics in elective caesarean section surgeries, in terms of intraoperative hemodynamic changes.
Detailed description
The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 80 patients planned for elective caesarean section surgeries , aged 18-40 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 40 patients each.
All cases will receive routine preparation for general anesthesia. All patients placed on the operating room will receive two large-bore vascular access. For anesthesia induction 2 mg/kg propofol and 0.5 mg/kg rocuronium will be used. Anesthesia will be maintained with 60% air, 40% oxygen and 2 MAC sevoflurane.Demographic data of the patients (age, height, weight), ASA score and surgical time will be recorded. During the operation, hemodynamic parameters will be recorded just before the drugs are given and at the 1st, 5th, 10th, 15th, 20th, 25th and 30th minutes after the drug is given. In addition, intraoperative blood loss and the need for additional uterotonics throughout the surgery will be recorded. All data will be recorded and statistical analysis will be made.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In 80 pregnant patients scheduled for elective cesarean section, patients will be randomly assigned to receive 5 IU oxytocin or 100 μg carbetocin IV bolus intraoperatively after the birth of the baby.
| Arm | Type | Receives |
|---|---|---|
| Oxytocin (Group-O) | Active comparator | Procedure: Group-OGroup-O: Oxytocin group (n:40). In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered. |
| Carbetocin (Group-C) | Experimental | Procedure: Group-CGroup-C: Carbetocin group (n:40). In cesarean surgery, 100 μg carbetocin IV bolus will be administered after the baby delivered. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients scheduled for caesarean sections
- Between 18-40 years
- ASA I-II group
- Those who will undergo general anesthesia
- Those between 35-40 weeks of pregnancy
Key exclusion criteria (7 listed)
- Those who prefer spinal or epidural anesthesia
- Those who are outside the age range of 18-40
- Those who are ASA III and above
- Those with HT, DM, cardiac and respiratory diseases
- Preeclampsia, eclampsia, HELLP
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 |
|---|---|---|
| Group-CAlso: Group Carbetosin100 iu carbetosin administered to carbetocin group | Procedure or surgery | Carbetocin (Group-C) |
| Group-OAlso: Group OxytocineIn cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered. | Procedure or surgery | Oxytocin (Group-O) |
Primary outcome
Uterine tonus
Time frame: For 30 minutes after carbetocin administration.
The effect of carbetocin on uterine tone will be evaluated by the surgical team using a numerical scoring scale between 0-10. A score of 0 will indicate atony, and a score of 10 will indicate full contraction.
Additional uterotonic drug requirement
Time frame: For 30 minutes after carbetocin administration.
If the uterine tone is 7 or below, the surgical team will perform uterine massage, and in patients who do not see a sufficient increase in uterine tone, an additional uterotonic, 0.2 mg methylergonavine (Methyl ampoule 0.2 mg/ml) will be administered IM by the anesthesia team and recorded.
3 secondary outcomes
Intraoperative bleeding
Time frame: from drug administration to the end of surgery.
Mean Blood Pressure
Time frame: Intraoperatively every 5 minutes
Heart Rate
Time frame: Intraoperatively every 5 minutes
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 4 May 2025.
- Background: PubMed 27347181He G, Li LI, Guan E, Chen J, Qin YI, Xie Y. Fentanyl inhibits the progression of human gastric carcinoma MGC-803 cells by modulating NF-kappaB-dependent gene expression in vivo. Oncol Lett. 2016 Jul;12(1):563-571. doi: 10.3892/ol.2016.4619. Epub 2016 May 25.
- Background: PubMed 35370716Dutriez-Casteloot I, Emmanuelli V, Wiart JF, Tavernier A, Besengez C, Storme L, Houfflin-Debarge V. Long-Lasting Analgesia With Transdermal Fentanyl: A New Approach in Rat Neonatal Research. Front Pharmacol. 2022 Mar 17;13:798011. doi: 10.3389/fphar.2022.798011. eCollection 2022.
- Background: PubMed 29936450Clemensen J, Rasmussen LV, Abelson KSP. Transdermal Fentanyl Solution Provides Long-term Analgesia in the Hind-paw Incisional Model of Postoperative Pain in Male Rats. In Vivo. 2018 Jul-Aug;32(4):713-719. doi: 10.21873/invivo.11299.
- Individual participant dataSharing planned: Yes. Study protocol anda statistical analysis plan will be share with other researchers
Related trials for Cesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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.
Şükran ŞS Sevimli, Assoc.Prof study director
Van Yüzüncü Yıl University Van/Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-C and Group-O in people with Cesarean Section, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 6 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: looking for participants now, as of the sponsor's last update on 4 May 2025. 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 Turkey (Türkiye). 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.
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 Nurettin NK Kurt, assoc.Prof. (+90 4322150473 ext. 6080, dr.nurettinkurt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine tonus (time frame: For 30 minutes after carbetocin administration.). 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?
On the ClinicalTrials.gov record for NCT06956365, which also lists 3 linked publications.
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 4 May 2025.