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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