Oxytocin vs Carbetocin at Cesarean Delivery in Women With Morbid Obesity

NCT04902729 | Completed

• 1 other identifier: 21-03
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug for the active management of third stage labor, to reduce the risk of PPH and help deliver the placenta. Carbetocin is currently recommended by the SOGC (Society of Obstetricans \& Gynecologists of Canada), and is a relatively newer drug with a longer duration of action. It has been previously demonstrated that women with elevated BMI require higher doses of these drugs to induce adequate uterine contraction and dose finding studies undertaken at Mount Sinai Hospital have shown that the ED 90 in obese patients to be carbetocin 80 mcg and oxytocin 1IU. Furthermore, previous studies have indicated that the use of carbetocin over oxytocin in non-obese popultion is associated with reduced bleeding and requirement of additional uterotonic medications. No study has directly compared the two drugs in obese parturients in a head to head clinical trial; therefore a double-blind randomized controlled trial is necessary to show the non-inferiority of carbetocin against the current standard of care at Mount Sinai hospital, which is oxytocin.

Conditions

Post Partum Hemorrhage

Keywords

pregnancy; postpartum hemorrhage; cesarean delivery; carbetocin; duratocin; oxytocin

Outcome Measures

Primary Outcomes (1)

• Uterine Tone 3 minutes

  The primary outcome will be the intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 3 minutes, from the completion of delivery of the drug, utilising a VNRS scale of 0-10.

  3 minutes

Secondary Outcomes (20)

• Uterine Tone 5 minutes

  5 min

• Uterine Tone 10 minutes

  10 min

• Additional uterotonics - operating room

  1-2 hours, length of surgery will vary

• Additional uterotonics - Post Anesthesia Care Unit (PACU)

  4 hours

• Additional uterotonics - 24 hours

  24 hours

Study Arms (2)

Oxytocin 1IU

ACTIVE COMPARATOR

Oxytocin 1IU, administered intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby, followed by infusion 80 mU/min (40 IU in 1L given at a rate of 120 mL/h).

Drug: Oxytocin

Carbetocin 80mcg

ACTIVE COMPARATOR

Carbetocin 80mcg, administered intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.

Drug: Carbetocin

Interventions

Carbetocin DRUG

Patient is given carbetocin (80mcg) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.

Also known as: Duratocin

Carbetocin 80mcg

Oxytocin DRUG

Patient is given oxytocin (1IU) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby, followed by infusion 80 mU/min (40 IU in 1L given at a rate of 120 mL/h).

Also known as: Pitocin

Oxytocin 1IU

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI≥40 kg/m2
• Elective cesarean delivery under spinal, epidural, or combined spinal-epidural anaesthesia
• Written informed consent
• Full term pregnancy (37+0 to 40+6 weeks gestation)
• Non-labouring patients

You may not qualify if:

• Refusal to give written informed consent
• Allergy or hypersensitivity to carbetocin or oxytocin
• Laboring patients
• Need for general anaesthesia
• Conditions that predispose to uterine atony and postpartum haemorrhage including but not limited to:
• Placenta previa
• Multiple gestations
• Preeclampsia
• Eclampsia
• Polyhydramnios
• Uterine fibroids
• Previous history of uterine atony and postpartum bleeding
• Bleeding diathesis
• Hepatic, renal, and cardiovascular disease

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• Turner W, Boonstra L, Maxwell C, Downey K, Balki M. Oxytocin versus carbetocin at elective Cesarean delivery in parturients with class III obesity: a double-blind randomized controlled noninferiority trial. Can J Anaesth. 2025 Mar;72(3):426-435. doi: 10.1007/s12630-024-02891-2. Epub 2025 Jan 6.

  PMID: 39760981 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocin; Oxytocin

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

Study Officials

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: July 20, 2021
• Primary Completion: December 8, 2022
• Study Completion: December 9, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)