Effects of Oxytocin and Carbetocin on Renal System in Cesarean Sections

NCT03939806 | Unknown FDA Drug

• 1 other identifier: CO2019
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (3)

• Urine volume

  Total amount of intraoperative urine output in milliliters

  Intraoperative period

• Urinary sodium

  The change in urinary sodium content (milligrams) compared to the preoperative period

  Preoperative, Postoperative 2nd, 4th, 24th hours

• Blood sodium

  The change in blood sodium content (milligrams) compared to the preoperative period

  Preoperative, Postoperative 2nd, 4th, 24th hours

Secondary Outcomes (4)

• Blood osmolality

  Preoperative, Postoperative 2nd, 4th, 24th hours

• Blood loss

  Intraoperative period

• Need for additional uterotonics

  Starting from the preoperative period, ending at the 24th postoperative hour

• Blood transfusion

  Starting from the clamping of the umbilical cord, ending at the 24th postoperative hour

Study Arms (2)

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

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

Interventions

Oxytocin DRUG

To be given to Oxytocin group following the clamping of the umbilical cord

Oxytocin

Carbetocin DRUG

To be given to Carbetocin group following the clamping of the umbilical cord

Carbetocin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Term (\>37 weeks of gestation) uncomplicated pregnant women undergoing elective cesarean section

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ufuk University: lead

Study Sites (1)

Ufuk University Faculty of Medicine Hospital

Ankara, Balgat, 06510, Turkey (Türkiye)

Location

Related Publications (2)

• Larciprete G, Montagnoli C, Frigo M, Panetta V, Todde C, Zuppani B, Centonze C, Bompiani A, Malandrenis I, Cirese A, Valensise H. Carbetocin versus oxytocin in caesarean section with high risk of post-partum haemorrhage. J Prenat Med. 2013 Jan;7(1):12-8.

  PMID: 23741542 BACKGROUND

• Engstrom T, Barth T, Melin P, Vilhardt H. Oxytocin receptor binding and uterotonic activity of carbetocin and its metabolites following enzymatic degradation. Eur J Pharmacol. 1998 Aug 21;355(2-3):203-10. doi: 10.1016/s0014-2999(98)00513-5.

  PMID: 9760035 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; carbetocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Gamze S Çağlar, Prof.Dr.

CONTACT

+903122044000; gamzesinem@hotmail.com

Baturay K Kazbek, MD

CONTACT

+903122044000; bkkazbek@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 7, 2019
• Study Start: May 1, 2019
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)