Carbetocin at Cesarean Delivery for Labor Arrest

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01725243
First received: November 8, 2012
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage
Drug: Carbetocin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Carbetocin at Cesarean Delivery for Labor Arrest: A Dose Finding Study

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • need for additional uterotonics [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • uterine tone [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
    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.

  • uterine tone [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    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

  • need for additional uterotonic [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Need for delayed additional uterotonics within 24 hours after delivery outside the OR.

  • Blood loss [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Estimated blood loss will be calculated using blood results prior to the cesarean delivery and 24 hours post-delivery.

  • side effects [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    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


Enrollment: 40
Study Start Date: November 2012
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Duratocin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725243

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Mrinalini Balki, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01725243     History of Changes
Other Study ID Numbers: 12-07
Study First Received: November 8, 2012
Last Updated: May 28, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
pregnancy
postpartum hemorrhage
Cesarean delivery
carbetocin
failure to progress in labor

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Carbetocin
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014