Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery

NCT06333340 | Recruiting

• 1 other identifier: 24-03
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH. This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa. The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors.

Conditions

Post Partum Hemorrhage

Keywords

oxytocin; carbetocin; cesarean delivery; pregnancy

Outcome Measures

Primary Outcomes (1)

• Proportion of parturients requiring additional uterotonic agents intraoperatively

  The proportion of patients who are administered additional uterotonic agents intraoperatively will be divided by the total number of patients assigned to the same treatment arm, for each of the 2 groups: oxytocin and carbetocin.

  90 minutes

Secondary Outcomes (25)

• Uterine Tone 3 minutes

  3 minutes

• Uterine Tone 5 minutes

  5 minutes

• Uterine Tone 10 minutes

  10 minutes

• Calculated blood loss (CBL)

  24 hours

• Semi-quantitative blood loss (SQBL)

  2 hours

Study Arms (2)

Oxytocin 5IU

ACTIVE COMPARATOR

IV oxytocin 5 IU diluted in 10 mL normal saline over 1 min followed by continuous infusion of 250 mIU/min over 4 hours.

Drug: Oxytocin

Carbetocin 100mcg

ACTIVE COMPARATOR

IV carbetocin 100 mcg diluted in 10 mL normal saline over 1 min followed by placebo infusion for 4 hours after the delivery of the fetus.

Drug: Carbetocin

Interventions

Oxytocin DRUG

Patient is given oxytocin 5 IU diluted in 10 mL normal saline, administered intravenously over 1 min, followed by continuous infusion of 250 mIU/min over 4 hours.

Also known as: Pitocin

Oxytocin 5IU

Carbetocin DRUG

Patient is given carbetocin 100 mcg diluted in 10 mL normal saline, administered intravenously over 1 min, followed by placebo infusion for 4 hours.

Also known as: Duratocin

Carbetocin 100mcg

Eligibility Criteria

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

You may qualify if:

• Overdistended uterus due to:
• Polyhydramnios (amniotic fluid index \>24 cm)
• Fetal macrosomia reported on prenatal ultrasound \>90th centile or \> 4000 gm
• Multiple gestation
• History of uterine atony/PPH (documented with blood loss of \>1000 ml, blood transfusion, use surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization)
• Obesity with body mass index (BMI) \>40 kg/m2
• Diabetes mellitus on treatment
• Preeclampsia on treatment
• Placenta previa

You may not qualify if:

• Valvular heart disease, arrhythmias, or heart failure
• Placenta accreta spectrum
• Bleeding disorder
• Anemia (\<100 g/dl)
• Allergy or sensitivity to oxytocin or carbetocin

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

RECRUITING

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

Study Officials

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mrinalini Balki, MD

CONTACT

416-586-4800; mrinalini.balki@uhn.ca

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: March 15, 2024
• First Posted: March 27, 2024
• Study Start: January 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)