search
Back to results

Carbetocin at Elective Cesarean Delivery Part 2

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Carbetocin
Carbetocin
Carbetocin
Carbetocin
Carbetocin
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring pregnancy, postpartum hemorrhage, Cesarean delivery, carbetocin

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • All patients planned for elective cesarean delivery under spinal anesthesia.
  • All patients who give written informed consent to participate in this study.

Exclusion Criteria:

  • All patients who refuse to give written informed consent.
  • All patients who claim allergy or hypersensitivity to carbetocin or oxytocin.
  • All patients with 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.
  • All patients with hepatic, renal, and vascular disease,
  • All patients requiring general anesthesia prior to the administration of the study drug.

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Carbetocin 20mcg

Carbetocin 40mcg

Carbetocin 60mcg

Carbetocin 80mcg

Carbetocin 100mcg

Arm Description

Outcomes

Primary Outcome Measures

Uterine tone
The obstetrician will assess uterine tone by palpation. Uterine tone will be rated as satisfactory (firm) or unsatisfactory (boggy).

Secondary Outcome Measures

Uterine tone
Uterine tone will be assessed by palpation 2 hours post-delivery by the nurse/obstetrician in the recovery room.
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.
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

Full Information

First Posted
September 1, 2011
Last Updated
March 23, 2012
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01428817
Brief Title
Carbetocin at Elective Cesarean Delivery Part 2
Official Title
Carbetocin at Elective Cesarean Delivery: A Dose Finding Study (Part 2)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.
Detailed Description
The Society of Obstetricians and Gynecologists of Canada (SOGC) recently recommended a 100mcg intravenous bolus dose of carbetocin following Cesarean delivery. Studies thus far show that carbetocin may be just as effective as oxytocin in promoting uterine contraction, with a similar side effect profile. In addition, patients receiving carbetocin may experience less blood loss, and require less additional uterotonics when compared with oxytocin. A dose response study conducted by Cordovani et al suggested no difference in efficacy of uterine contraction for doses of carbetocin between 80-120mcg. Additionally, hypotension was noted for all dose groups studied. The results of this follow-up study will define the minimum required dose of carbetocin for uterine contraction, thus minimizing unnecessary side effects, improving quality and safety of patient care. It may also contribute in establishing carbetocin as a substitute to oxytocin for elective cesarean section at our institution as well as others.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
pregnancy, postpartum hemorrhage, Cesarean delivery, carbetocin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbetocin 20mcg
Arm Type
Active Comparator
Arm Title
Carbetocin 40mcg
Arm Type
Active Comparator
Arm Title
Carbetocin 60mcg
Arm Type
Active Comparator
Arm Title
Carbetocin 80mcg
Arm Type
Active Comparator
Arm Title
Carbetocin 100mcg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
Duratocin
Intervention Description
20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
Duratocin
Intervention Description
40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
Duratocin
Intervention Description
60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
Duratocin
Intervention Description
80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
Duratocin
Intervention Description
100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Primary Outcome Measure Information:
Title
Uterine tone
Description
The obstetrician will assess uterine tone by palpation. Uterine tone will be rated as satisfactory (firm) or unsatisfactory (boggy).
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Uterine tone
Description
Uterine tone will be assessed by palpation 2 hours post-delivery by the nurse/obstetrician in the recovery room.
Time Frame
2 hours
Title
Blood loss
Description
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.
Time Frame
48 hours
Title
Side effects
Description
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
Time Frame
2 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients planned for elective cesarean delivery under spinal anesthesia. All patients who give written informed consent to participate in this study. Exclusion Criteria: All patients who refuse to give written informed consent. All patients who claim allergy or hypersensitivity to carbetocin or oxytocin. All patients with 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. All patients with hepatic, renal, and vascular disease, All patients requiring general anesthesia prior to the administration of the study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose CA Carvalho, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24158878
Citation
Anandakrishnan S, Balki M, Farine D, Seaward G, Carvalho JC. Carbetocin at elective Cesarean delivery: a randomized controlled trial to determine the effective dose, part 2. Can J Anaesth. 2013 Nov;60(11):1054-60. doi: 10.1007/s12630-013-0028-2. Epub 2013 Sep 25.
Results Reference
derived

Learn more about this trial

Carbetocin at Elective Cesarean Delivery Part 2

We'll reach out to this number within 24 hrs