Carbetocin at Cesarean Delivery for Labor Arrest

May 28, 2013 updated by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Carbetocin at Cesarean Delivery for Labor Arrest: A Dose Finding Study

In 2009, the Society of Obstetricians and Gynecologists Canada, which produces national clinical guidelines on important women's health issues, recommended that a bolus of carbetocin 100 mcg into your vein should be used at elective cesarean delivery instead of oxytocin infusion for the prevention of bleeding after you deliver your baby. Similar to oxytocin, carbetocin has side effects that are dose-related. Although 100 mcg has been the recommend dose, studies in nonlaboring women suggest that doses lower than 100 mcg may be used to achieve the same degree of uterine contractility with less side effects. So far, the ideal dose to be used in cesarean sections for labouring women who have failure to progress in labour (failure of your cervix to dilate adequately to 10cm or the baby's head not descending the birth canal) has not been determined. This study is designed to determine the minimum carbetocin dose required during cesarean delivery for 'failure to progress' to achieve the best effect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

The evidence reported for Carbetocin use in the literature has mostly been based upon low risk non-laboring patients undergoing elective cesarean deliveries. At present, only 2 studies have looked at the use of Carbetocin in low risk patients requiring emergency cesarean deliveries. The minimum effective dose (ED90) of carbetocin in laboring women has not been determined so far. Similar to oxytocin, the ED90 of Carbetocin is likely to be higher in laboring women undergoing Cesarean deliveries as compared to the non-laboring women, due to the effect of the desensitization phenomenon.

This study will be conducted as a prospective, randomized, up-down sequential allocation trial. The success or fail of a patient in the study will determine the dose given to future patients. Dosage will be increased for patients following a failed case, and kept the same for patients following successful cases. Following a successful case, there is also a 1 in 9 chance that the dose will be decreased for the next patient.

The results of this study will establish the minimum effective dose of carbetocin for uterine contraction at cesarean delivery for labor arrest. This will likely minimize unnecessary side effects caused by a large bolus dose of the drug, and improve quality and safety of patient care.

Study Type

Interventional

Enrollment (Actual)

40

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All patients who have given written informed consent to participate in this study.
  • All patients planned for uncomplicated low transverse cesarean delivery secondary to labor arrest, under epidural anesthesia.
  • ≥37 week pregnancy
  • Singleton pregnancy
  • Patients who have received oxytocin for at least 4 hours for labor augmentation
  • ASA 1 or 2

Exclusion Criteria:

  • Refusal or inability to obtain informed consent.
  • All patients who claim allergy or hypersensitivity to oxytocin and carbetocin.
  • Previous history of uterine atony or PPH
  • Risk factors for PPH such as pre-eclampsia, polyhydramnios, uterine fibroids, bleeding diathesis and chorioamnionitis etc.
  • Abnormal placental implantation (known or suspected)
  • > 3 cesarean sections in the past
  • Previous classic uterine incision
  • Macrosomia - Estimated fetal weight > 4500g
  • Hemoglobin < 100g/L
  • Cesarean section under general anesthesia
  • ASA 3 and 4 or patients with hepatic, renal, cardiac (eg. Coronary artery disease) and vascular disease
  • Genital development problems (eg. Abnormal uterus, cervix, vagina, etc.)
  • Uncontrolled hypotension or hypertension
  • Uncontrolled diabetes
  • Abnormal heart rhythms and bradycardia
  • Drug abusers

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Carbetocin 10mcg
Carbetocin 10mcg IV, once following delivery.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery. Doses: 10, 20, 40, 60, 80, 100, 120 or 140mcg
Other Names:
  • Duratocin
ACTIVE_COMPARATOR: Carbetocin 20mcg
Carbetocin 20mcg IV, once following delivery.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery. Doses: 10, 20, 40, 60, 80, 100, 120 or 140mcg
Other Names:
  • Duratocin
ACTIVE_COMPARATOR: Carbetocin 40mcg
Carbetocin 40mcg IV, once following delivery.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery. Doses: 10, 20, 40, 60, 80, 100, 120 or 140mcg
Other Names:
  • Duratocin
ACTIVE_COMPARATOR: Carbetocin 60mcg
Carbetocin 60mcg IV, once following delivery.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery. Doses: 10, 20, 40, 60, 80, 100, 120 or 140mcg
Other Names:
  • Duratocin
ACTIVE_COMPARATOR: Carbetocin 80mcg
Carbetocin 80mcg IV, once following delivery.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery. Doses: 10, 20, 40, 60, 80, 100, 120 or 140mcg
Other Names:
  • Duratocin
ACTIVE_COMPARATOR: Carbetocin 100mcg
Carbetocin 100mcg IV, once following delivery.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery. Doses: 10, 20, 40, 60, 80, 100, 120 or 140mcg
Other Names:
  • Duratocin
ACTIVE_COMPARATOR: Carbetocin 120mcg
Carbetocin 120mcg IV, once following delivery.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery. Doses: 10, 20, 40, 60, 80, 100, 120 or 140mcg
Other Names:
  • Duratocin
ACTIVE_COMPARATOR: Carbetocin 140mcg
Carbetocin 140mcg IV, once following delivery.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery. Doses: 10, 20, 40, 60, 80, 100, 120 or 140mcg
Other Names:
  • Duratocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
need for additional uterotonics
Time Frame: 30 minutes
need for additional uterotonics in the OR at the time of cesarean section based upon the assessment of unsatisfactory/indeterminate uterine tone in response to the single bolus of carbetocin.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uterine tone
Time Frame: 10 minutes
Incidence of satisfactory, unsatisfactory and indeterminate uterine tone at every minute for five minutes and at 10 minutes following the completion of the injection of carbetocin.
10 minutes
uterine tone
Time Frame: 2 hours
Incidence of satisfactory, unsatisfactory/ indeterminate uterine tone as determined by the obstetrician/nurse after trans-abdominal palpation of the uterus in PACU within 2 hours of delivery of the placenta
2 hours
need for additional uterotonic
Time Frame: 24 hours
Need for delayed additional uterotonics within 24 hours after delivery outside the OR.
24 hours
Blood loss
Time Frame: 24 hours
Estimated blood loss will be calculated using blood results prior to the cesarean delivery and 24 hours post-delivery.
24 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

November 1, 2012

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

November 8, 2012

First Submitted That Met QC Criteria

November 8, 2012

First Posted (ESTIMATE)

November 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 28, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-07

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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