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Effects of Oxytocin and Carbetocin on Renal System in Cesarean Sections

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ClinicalTrials.gov Identifier: NCT03939806
Recruitment Status : Unknown
Verified May 2019 by Gamze Sinem Caglar, Ufuk University.
Recruitment status was:  Not yet recruiting
First Posted : May 7, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Gamze Sinem Caglar, Ufuk University

Study Description
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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 Intervention/treatment
Postpartum Hemorrhage Drug: Oxytocin Drug: Carbetocin

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Groups and Cohorts
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Group/Cohort 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
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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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939806


Contacts
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Contact: Gamze S Çağlar, Prof.Dr. +903122044000 gamzesinem@hotmail.com
Contact: Baturay K Kazbek, MD +903122044000 bkkazbek@gmail.com

Locations
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Turkey
Ufuk University Faculty of Medicine Hospital
Ankara, Balgat, Turkey, 06510
Contact: Baturay K Kazbek, MD    +903122044000    bkkazbek@gmail.com   
Sponsors and Collaborators
Ufuk University
More Information
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Publications:

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Responsible Party: Gamze Sinem Caglar, Clinical Professor, Ufuk University
ClinicalTrials.gov Identifier: NCT03939806    
Other Study ID Numbers: CO2019
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
 Uterine Hemorrhage
Oxytocin
Carbetocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs