Carbetocin at Elective Cesarean Delivery Part 3

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01651130
First received: July 24, 2012
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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 study to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is at least 20mcgs (or perhaps below) in women undergoing elective Cesarean delivery.


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 Elective Cesarean Deliveries: A Dose-finding Study Part 3

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Uterine tone [ Time Frame: 2 minutes ] [ Designated as safety issue: Yes ]
    The obstetrician will assess uterine tone by palpation. Uterine tone will be rated as satisfactory (firm) or unsatisfactory (boggy). Unsatisfactory uterine tone will be treated with oxytocin as per the obstetrician.


Secondary Outcome Measures:
  • Uterine tone [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    Uterine tone will be assessed by palpation 2 hours post-delivery by the nurse/obstetrician in the recovery room.

  • Blood loss [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    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 [ 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: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Carbetocin 100mcg
Carbetocin 100mcg, once following delivery of the fetal head.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery of the fetal head. Doses: 2, 5, 10, 15, 20 or 100mcg
Other Name: Duratocin
Active Comparator: Carbetocin 20mcg
Carbetocin 20mcg, once following delivery of the fetal head.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery of the fetal head. Doses: 2, 5, 10, 15, 20 or 100mcg
Other Name: Duratocin
Active Comparator: Carbetocin 15mcg
Carbetocin 15mcg, once following delivery of the fetal head.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery of the fetal head. Doses: 2, 5, 10, 15, 20 or 100mcg
Other Name: Duratocin
Active Comparator: Carbetocin 10mcg
Carbetocin 10mcg, following delivery of the fetal head.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery of the fetal head. Doses: 2, 5, 10, 15, 20 or 100mcg
Other Name: Duratocin
Active Comparator: Carbetocin 5mcg
Carbetocin 5mcg, following delivery of the fetal head.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery of the fetal head. Doses: 2, 5, 10, 15, 20 or 100mcg
Other Name: Duratocin
Active Comparator: Carbetocin 2mcg
Carbetocin 2mcg, following delivery of the fetal head.
Drug: Carbetocin
Carbetocin IV, over 1 minute following delivery of the fetal head. Doses: 2, 5, 10, 15, 20 or 100mcg
Other Name: Duratocin

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. Two dose response studies conducted at our institution (by Cordovani et al, and Anandakrishnan et al) suggested no difference in efficacy of uterine contraction for doses of carbetocin between 20-120mcg. Hypotension was noted for all dose groups studied.

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 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.

  Eligibility

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

Inclusion Criteria:

  • Patients planned for elective cesarean delivery under spinal anesthesia
  • Patients who give written informed consent to participate

Exclusion Criteria:

  • Patients who refuse to give written informed consent
  • Patients who claim allergy or hypersensitivity to carbetocin or oxytocin
  • 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.
  • Patients with hepatic, renal, and vascular disease
  • Patients requiring general anesthesia prior to the administration of the study drug.
  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: NCT01651130

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

No publications provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01651130     History of Changes
Other Study ID Numbers: 12-04
Study First Received: July 24, 2012
Last Updated: May 28, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
pregnancy
postpartum hemorrhage
Cesarean delivery
carbetocin

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 August 28, 2014