Carbetocin Clinical Trial
Official title:
Compariıson Of The Effects Of Carbetocin And Oxytocin, Which Are Uterotonic Agents, In C-Section Operations
Obstetric hemorrhage is the most common cause of maternal mortality worldwide and its incidence is estimated to be approximately 24%. A series of studies has shown that the risk of serious postpartum hemorrhage decreases with correct and active management in the third stage of labor. And the routine use of uterotonic agents underlies effective management. It has been reported that the routine use of uterotonic agents (oxytocin, carbetocin, ergometrine, etc.) reduces the risk of postpartum bleeding by 40% on average. However, the uterotonic agent and dose protocol are still unclear. Oxytocin is the most preferred agent for postpartum hemorrhage prophylaxis after vaginal and cesarean delivery in cases without risk factors, as it has a rapid onset of effect, does not increase blood pressure, and does not cause a retained placenta. In cases where oxytocin cannot be used, other agents of choice are ergot derivatives and misoprostol. The use of carbetocin, a long-acting oxytocin analogue, is now recommended in the guidelines for risky vaginal deliveries and postpartum hemorrhage prophylaxis after C-section. Carbetocin also reduces the need for additional uterotonics. Although carbetocin has been approved for use by the ministry of health, it still has limited clinical use in Turkey. It is vital for the medical community to have more experience with using carbetocin, an agent cited in medical guidelines and is also available in our country, and to share their experiences on academic platforms. This study intends to investigate oxytocin and carbetocin, which are uterotonic agents used during C-section, in terms of haemodynamic changes they cause, their effects on the uterine tone and on bleeding as well as their side effects (flushing, headache, back pain, hypertension and tachycardia, nausea-vomiting, etc.), to determine if there are any differences between them and share our insights with the reader.
| Status | Not yet recruiting |
| Enrollment | 200 |
| Est. completion date | June 21, 2023 |
| Est. primary completion date | May 31, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility | Inclusion Criteria: - 18-45 years old - Pregnant women to have a C-section, - Subjects with no history of oxytocin allergy, At term, no multiple pregnancies, elective C-section Exclusion Criteria: Subjects refusing to take part, - Subjects with a history of oxytocin allergy, Subjects scheduled for an emergency C-section, Multiple pregnancies, Having been diagnosed with diabetes mellitus |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | EÜTF | Bornova | I?zmi?r |
| Lead Sponsor | Collaborator |
|---|---|
| Ege University |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effect of uterotonic agents on uterine tone | uterine tone (standardized as Very good, Good, Sufficient, Atony), | intraoperative | |
| Primary | hemorrhage | haemoglobin concentration | haemoglobin levels before and after 6 hours. | |
| Secondary | in terms of haemodynamic changes uterotonic agents cause | Blood pressure (in mmHg),hypotansion | intraoperative time, after 30 minute | |
| Secondary | side effects of uterotonic agents | lushing, headache, back pain, hypertension and tachycardia, nausea-vomiting | postoperative,24 hours after caesarean section |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03959436 -
Database Evaluating Outcomes of Using Carbetocin as the Primary Uterotonic Following Cesarean Delivery
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