Renal Effects of Carbetocin and Oxytocin in Cesarean Section for Preventing Post-partum Haemorrhage: a Prospective Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Urinary sodium
Study Overview
Brief Summary
The aim of this study is to evaluate the renal outcome of patients undergoing elective C/S where oxytocin or carbetocin is used for postpartum hemorrhage prophylaxis.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Term (>37 weeks of gestation) uncomplicated pregnant women undergoing elective cesarean section
Exclusion Criteria
- •Patients refusing to participate in the study
- •Complicated pregnancies
- •Patients with risk factors for postpartum hemorrhage
- •Contraindications for oxytocin or carbetocin usage
- •Patients with known renal diseases
- •Preterm births (<37 weeks of gestation)
Arms & Interventions
Oxytocin
This group will be given 3 IU / 3 ml oxytocin (intravenously) after the clamping of the umbilical cord. Uterine tonus will be assessed after 60 seconds and if it is lower than 7, oxytocin 3 IU / 3 ml will be repeated, up to a maximum of three times. If uterine tonus is still lower than 7, rescue uterotonics such as intramuscular methylergonovine or intravenous misoprostol will be administered.
Intervention: Oxytocin (Drug)
Carbetocin
This group will be given 100 mcg / 3 ml carbetocin (intravenously) after the clamping of the umbilical cord. If uterine tonus is lower than 7, rescue uterotonics such as intramuscular methylergonovine or intravenous misoprostol will be administered.
Intervention: Carbetocin (Drug)
Outcomes
Primary Outcomes
Urinary sodium
Time Frame: Preoperative, Postoperative 2nd, 4th, 24th hours
The change in urinary sodium content (milligrams) compared to the preoperative period
Urine volume
Time Frame: Intraoperative period
Total amount of intraoperative urine output in milliliters
Blood sodium
Time Frame: Preoperative, Postoperative 2nd, 4th, 24th hours
The change in blood sodium content (milligrams) compared to the preoperative period
Secondary Outcomes
- Blood transfusion(Starting from the clamping of the umbilical cord, ending at the 24th postoperative hour)
- Need for additional uterotonics(Starting from the preoperative period, ending at the 24th postoperative hour)
- Blood osmolality(Preoperative, Postoperative 2nd, 4th, 24th hours)
- Blood loss(Intraoperative period)
Investigators
Gamze Sinem Caglar
Clinical Professor
Ufuk University