An interventional study of Group-C and Group-O in Cesarean Section, sponsored by Yuzuncu Yıl University. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Yuzuncu Yıl University · Not applicable, Interventional, and Supportive care
To compare the effects of oxytocin and carbetocin, used as uterotonics in elective caesarean section surgeries, in terms of intraoperative hemodynamic changes.
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.
213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 160 interventional studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group-O: Oxytocin group (n:40). In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered.
Procedure: Group-O
Group-C: Carbetocin group (n:40). In cesarean surgery, 100 μg carbetocin IV bolus will be administered after the baby delivered.
Procedure: Group-C
100 iu carbetosin administered to carbetocin group
Also known as: Group Carbetosin
In cesarean surgery, 5 IU of oxytocin will be administered after the baby delivered.
Also known as: Group Oxytocine
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.
Time frame: 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.
Time frame: For 30 minutes after carbetocin administration.
Intraoperative bleeding
Total intraoperative bleeding was recorded by calculating and estimating the aspirator volume, pad-sponge-compress count and surgical area.
Time frame: 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.
Time frame: Intraoperatively every 5 minutes
Heart Rate
Heart rate will be measured every 5 minutes intraoperatively using a noninvasive method.
Time frame: Intraoperatively every 5 minutes
Plan to share: Yes — Study protocol anda statistical analysis plan will be share with other researchers
Supporting information: Study protocol, Statistical analysis plan
Time frame: 10 months
Access criteria: The access can be provided via the e-mail addresses below dr.nurettinkurt@gmail.com
Started May 2024 (actual). Primary completion is estimated for May 2025, 12 months after the start.
Of 31 non-industry interventional studies with no phase under Blood Loss, Surgical, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's planned 12 months is close to that.
Counting every sponsor, half of 40 studies reached it within 11 months; a quarter within 5 and three quarters within 23.
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