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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Effects of Oxytocin and Carbetocin on Renal System in Cesarean Sections

Clinicaltrials.gov identifier NCT03939806

Recruitment Status Not yet recruiting

First Posted May 7, 2019

Last update posted May 13, 2019

Study Description

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.

  • Condition or Disease:Postpartum Hemorrhage
  • Intervention/Treatment: Drug: Oxytocin
    Drug: Carbetocin
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 100 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Renal Effects of Carbetocin and Oxytocin in Cesarean Section for Preventing Post-partum Haemorrhage: a Prospective Randomized Study
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: June 2019
  • Estimated Study Completion Date: June 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: 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.
Drug: Oxytocin
To be given to Oxytocin group following the clamping of the umbilical cord
: 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.
Drug: Carbetocin
To be given to Carbetocin group following the clamping of the umbilical cord
Outcome Measures
  • Primary Outcome Measures: 1. Urine volume [ Time Frame: Intraoperative period ]
    Total amount of intraoperative urine output in milliliters
  • 2. Urinary sodium [ Time Frame: Preoperative, Postoperative 2nd, 4th, 24th hours ]
    The change in urinary sodium content (milligrams) compared to the preoperative period
  • 3. Blood sodium [ Time Frame: Preoperative, Postoperative 2nd, 4th, 24th hours ]
    The change in blood sodium content (milligrams) compared to the preoperative period
  • Secondary Outcome Measures: 1. Blood osmolality [ Time Frame: Preoperative, Postoperative 2nd, 4th, 24th hours ]
    The change in blood osmolality compared to the preoperative period
  • 2. Blood loss [ Time Frame: Intraoperative period ]
    The total volume of intraoperative blood loss
  • 3. Need for additional uterotonics [ Time Frame: Starting from the preoperative period, ending at the 24th postoperative hour ]
    Total dose (milligrams) of additional uterotonics administered
  • 4. Blood transfusion [ Time Frame: Starting from the clamping of the umbilical cord, ending at the 24th postoperative hour ]
    Total volume (milliliters) of blood transfused
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: The study population consists of term (gestational age greater than 37 weeks) pregnant women scheduled to undergo elective cesarean section.
Criteria

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)

Contacts and Locations
Contacts

Contact: Gamze S Çağlar, Prof.Dr. +903122044000 gamzesinem@hotmail.com

Contact: Baturay K Kazbek, MD +903122044000 bkkazbek@gmail.com

Locations

Turkey, Balgat
Ufuk University Faculty of Medicine Hospital
Ankara

Sponsors and Collaborators

Ufuk University

More Information