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Carbetocin at Elective Cesarean Delivery Part 2

This study has been completed.
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01428817
First received: September 1, 2011
Last updated: March 23, 2012
Last verified: March 2012

September 1, 2011
March 23, 2012
June 2011
December 2011   (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).
Same as current
Complete list of historical versions of study NCT01428817 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 2
Carbetocin at Elective Cesarean Delivery: A Dose Finding Study (Part 2)

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 to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is above 20mcgs and below 80mcgs 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. A dose response study conducted by Cordovani et al suggested no difference in efficacy of uterine contraction for doses of carbetocin between 80-120mcg. Additionally, hypotension was noted for all dose groups studied.

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: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postpartum Hemorrhage
  • Drug: Carbetocin
    20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
    Other Name: Duratocin
  • Drug: Carbetocin
    40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
    Other Name: Duratocin
  • Drug: Carbetocin
    60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
    Other Name: Duratocin
  • Drug: Carbetocin
    80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
    Other Name: Duratocin
  • Drug: Carbetocin
    100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
    Other Name: Duratocin
  • Active Comparator: Carbetocin 20mcg
    Intervention: Drug: Carbetocin
  • Active Comparator: Carbetocin 40mcg
    Intervention: Drug: Carbetocin
  • Active Comparator: Carbetocin 60mcg
    Intervention: Drug: Carbetocin
  • Active Comparator: Carbetocin 80mcg
    Intervention: Drug: Carbetocin
  • Active Comparator: Carbetocin 100mcg
    Intervention: Drug: Carbetocin
Anandakrishnan S, Balki M, Farine D, Seaward G, Carvalho JC. Carbetocin at elective Cesarean delivery: a randomized controlled trial to determine the effective dose, part 2. Can J Anaesth. 2013 Nov;60(11):1054-60. doi: 10.1007/s12630-013-0028-2. Epub 2013 Sep 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01428817
11-02
No
Dr. Jose C.A. Carvalho, 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
March 2012

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