Carbetocin at Elective Cesarean Delivery Part 2

March 23, 2012 updated by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Carbetocin at Elective Cesarean Delivery: A Dose Finding Study (Part 2)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Carbetocin 20mcg
Drug: Carbetocin
20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Active Comparator: Carbetocin 40mcg
Drug: Carbetocin
20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Active Comparator: Carbetocin 60mcg
Drug: Carbetocin
20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Active Comparator: Carbetocin 80mcg
Drug: Carbetocin
20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Active Comparator: Carbetocin 100mcg
Drug: Carbetocin
20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin
Drug: Carbetocin
100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Names:
  • Duratocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine tone
Time Frame: 2 minutes
The obstetrician will assess uterine tone by palpation. Uterine tone will be rated as satisfactory (firm) or unsatisfactory (boggy).
2 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine tone
Time Frame: 2 hours
Uterine tone will be assessed by palpation 2 hours post-delivery by the nurse/obstetrician in the recovery room.
2 hours
Blood loss
Time Frame: 48 hours
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
Side effects
Time Frame: 2 hours
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

This is where you will find people and organizations involved with this study.

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 1, 2011

First Submitted That Met QC Criteria

September 2, 2011

First Posted (Estimate)

September 5, 2011

Study Record Updates

Last Update Posted (Estimate)

March 26, 2012

Last Update Submitted That Met QC Criteria

March 23, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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