Carbetocin vs. Oxytocin at Elective Cesarean Section

NCT03168698 | Completed

• 1 other identifier: 17-01
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 2

Brief Summary

The study investigators are comparing 2 drugs (oxytocin and carbetocin) at 2 different dosages, to help prevent serious bleeding (hemorrhage) after cesarean deliveries. These drugs are used routinely to help contract the uterus and keep it contracted after the delivery of the baby and placenta; this reduces the amount of blood you might lose. At Mount Sinai Hospital, currently oxytocin is used, but its effect on the uterus is much shorter than that of carbetocin. Internationally, there is no consensus as to what the most effective drug to use is and at which dose. The Society of Obstetricians and Gynaecologists of Canada has recently revised its guidelines to suggest 100 micrograms (mcg) of carbetocin as the drug of choice at elective cesarean section. Guidelines from the United Kingdom and the United States currently suggest oxytocin at various doses as the drug of choice at elective cesarean sections. Previous studies at Mount Sinai Hospital have shown that lower doses of oxytocin, 0.35 International Units (IU), and carbetocin, 20 mcg, may be as effective as the higher recommended doses. The investigators plan to conduct a large study to confirm these findings so that they can use the most appropriate dose in the future. Furthermore, the investigators hope to demonstrate that side effects are lower with the lower dose regimens.

Conditions

Postpartum Hemorrhage

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Uterine Tone 2 minutes

  Intensity of uterine tone on a VNRS scale of 0-10 as evaluated by the obstetrician at 2 minutes after completion of injection of the bolus study drug.

  2 minutes

Secondary Outcomes (18)

• Uterine Tone 5 minutes

  5 minutes

• Uterine Tone 10 minutes

  10 minutes

• Additional uterotonics - operating room

  1 hour

• Additional uterotonics - 24 hours

  24 hours

• Estimated blood loss

  24 hours

Study Arms (4)

Carbetocin 20mcg

ACTIVE COMPARATOR

Carbetocin 20mcg, administered intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.

Drug: Carbetocin

Carbetocin 100mcg

ACTIVE COMPARATOR

Carbetocin 100mcg, administered intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.

Drug: Carbetocin

Oxytocin 0.5IU

ACTIVE COMPARATOR

Oxytocin 0.5IU, administered intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.

Drug: Oxytocin

Oxytocin 5IU

ACTIVE COMPARATOR

Oxytocin 5IU, administered intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.

Drug: Oxytocin

Interventions

Carbetocin DRUG

Patient is given carbetocin (20 or 100 mcg) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.

Also known as: Duratocin

Carbetocin 100mcg; Carbetocin 20mcg

Oxytocin DRUG

Patient is given oxytocin (0.5 or 5 IU) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.

Also known as: Pitocin

Oxytocin 0.5IU; Oxytocin 5IU

Eligibility Criteria

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

You may qualify if:

• Elective cesarean section under spinal anesthesia.
• Written informed consent to participate in this study.
• Full-term pregnancy
• Non labouring patients

You may not qualify if:

• Refusal to give written informed consent.
• Allergy or hypersensitivity to carbetocin or oxytocin.
• Labouring patients
• Need for general anesthesia
• Conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.
• Hepatic, renal, and cardiovascular disease.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (2)

McMaster University Medical Centre (MUMC)

Hamilton, Ontario, L8N 3Z5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

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 23, 2017
• First Posted: May 30, 2017
• Study Start: May 25, 2017
• Primary Completion: December 17, 2020
• Study Completion: December 18, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)