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Carbetocin at Elective Cesarean Delivery Part 2

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ClinicalTrials.gov Identifier: NCT01428817
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : March 26, 2012
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Carbetocin Not Applicable

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. 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Carbetocin at Elective Cesarean Delivery: A Dose Finding Study (Part 2)
Study Start Date : June 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Carbetocin 20mcg Drug: Carbetocin
20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Name: Duratocin

Active Comparator: Carbetocin 40mcg Drug: Carbetocin
40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Name: Duratocin

Active Comparator: Carbetocin 60mcg Drug: Carbetocin
60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Name: Duratocin

Active Comparator: Carbetocin 80mcg Drug: Carbetocin
80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Name: Duratocin

Active Comparator: Carbetocin 100mcg Drug: Carbetocin
100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
Other Name: Duratocin




Primary Outcome Measures :
  1. Uterine tone [ Time Frame: 2 minutes ]
    The obstetrician will assess uterine tone by palpation. Uterine tone will be rated as satisfactory (firm) or unsatisfactory (boggy).


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

  2. Blood loss [ Time Frame: 48 hours ]
    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.

  3. Side effects [ Time Frame: 2 hours ]
    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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428817


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Jose C.A. Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01428817     History of Changes
Other Study ID Numbers: 11-02
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: March 2012

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