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

July 24, 2012
May 28, 2013
June 2012
August 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01651130 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Carbetocin at Elective Cesarean Delivery Part 3
Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study Part 3

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postpartum Hemorrhage
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 100mcg
    Carbetocin 100mcg, once following delivery of the fetal head.
    Intervention: Drug: Carbetocin
  • Active Comparator: Carbetocin 20mcg
    Carbetocin 20mcg, once following delivery of the fetal head.
    Intervention: Drug: Carbetocin
  • Active Comparator: Carbetocin 15mcg
    Carbetocin 15mcg, once following delivery of the fetal head.
    Intervention: Drug: Carbetocin
  • Active Comparator: Carbetocin 10mcg
    Carbetocin 10mcg, following delivery of the fetal head.
    Intervention: Drug: Carbetocin
  • Active Comparator: Carbetocin 5mcg
    Carbetocin 5mcg, following delivery of the fetal head.
    Intervention: Drug: Carbetocin
  • Active Comparator: Carbetocin 2mcg
    Carbetocin 2mcg, following delivery of the fetal head.
    Intervention: Drug: Carbetocin
Khan M, Balki M, Ahmed I, Farine D, Seaward G, Carvalho JC. Carbetocin at elective Cesarean delivery: a sequential allocation trial to determine the minimum effective dose. Can J Anaesth. 2014 Mar;61(3):242-8. doi: 10.1007/s12630-013-0082-9. Epub 2013 Nov 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01651130
12-04
No
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Not Provided
Principal Investigator: Jose CA Carvalho, MD Mount Sinai Hospital, New York
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP