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Carbetocin at Elective Cesarean Delivery Part 3

This study is currently recruiting participants.
Verified July 2012 by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01651130
First received: July 24, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  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:

U.S. FDA Resources

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


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 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:

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651130

Contacts
Contact: Jose CA Carvalho, MD 416-586-4800 ext 2681 jose.carvalho@uhn.ca
Contact: Kristi Downey, MSc 416-586-4800 ext 2366 kristi.downey@uhn.ca

Locations
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G1X5
Contact: Jose CA Carvalho, MD     416-586-4800 ext 2681     jose.carvalho@uhn.ca    
Contact: Kristi Downey, MSc     416-586-4800 ext 2366     kristi.downey@uhn.ca    
Principal Investigator: Jose CA Carvalho, MD            
Sub-Investigator: Mubeen Khan, MD            
Sub-Investigator: Dan Farine, MD            
Sub-Investigator: Mrinalini Balki, MD            
Sub-Investigator: Gareth Seaward, MD            
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

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: July 24, 2012
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 May 16, 2013