Carbetocin at Elective Cesarean Delivery Part 4

Carbetocin at Elective Cesarean Deliveries: A Non-inferiority Study Between 20 and 100 Micrograms - Part 4

PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH in North America. However oxytocin has a very short duration of action, requiring a continuous infusion to achieve sustained uterotonic activity. Moreover large doses are associated with adverse effects like hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery to promote uterine contraction. In three studies recently performed at Mount Sinai Hospital, the investigators have found no difference in uterine contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus a larger trial comparing the minimum effective dose determined in the previous three trials with the standard 100 mcg dose is necessary to confirm these findings.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Drug: Carbetocin

Detailed Description

The current oxytocin regimen requires the administration of a continuous infusion to achieve sustained uterotonic activity, which can be associated with a number of side effects and unpredictable efficacy. Carbetocin in a single 100 mcg dose has apparently greater efficacy, with a similar side effect profile to that of oxytocin. In addition, some studies have also shown that there is less blood loss and less requirement for additional uterotonic drugs when carbetocin is administered. Studies conducted by the investigators group at Mount Sinai have shown similar efficacy between the doses ranging from 20 to 100 mcg of carbetocin. In the investigators study, the investigators are going to compare those two doses of carbetocin to determine that 20 mcg is not inferior to 100 mcg to produce adequate uterine tone in elective cesarean delivery. This study will be a randomized, double - blind, non inferiority study.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Elective cesarean delivery under spinal anesthesia.
• Written informed consent to participate in this study.
• Term pregnancy

Exclusion Criteria:

• Refusal to give written informed consent.
• Allergy or hypersensitivity to carbetocin or oxytocin.
• 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 vascular disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Carbetocin 20mcg; Patient is given carbetocin 20 mcg intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.	Drug: Carbetocin; Other Names: Duratocin
Active Comparator: Carbetocin 100mcg; Patient is given carbetocin 100 mcg intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.	Drug: Carbetocin; Other Names: Duratocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uterine tone	Uterine tone on a scale of 0-10 at 2 minutes after completion of injection of carbetocin.	2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean section.	48 hours
Uterine tone	Uterine tone on a scale of 0-10 at 5 minutes after completion of injection of carbetocin.	5 minutes
Additional uterotonic medication administration	2. The use of additional uterotonic at any time post administration of carbetocin up to 24 hours post delivery.	24 hours
Side Effects	Any of the following will be noted up to 2 hours post delivery: systolic blood pressure < 80% of pre-delivery values, tachycardia > 30% pre-delivery levels, bradycardia < 30% pre-delivery levels, other dysrhythmias, nausea, vomiting, chest pain, shortness of breath, headache, flushing, others	2 hours

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 22, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: pregnancy; postpartum hemorrhage; Cesarean delivery; carbetocin
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Carbetocin
• Other Study ID Numbers: 14-03