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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
  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 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 Intervention
Postpartum Hemorrhage
Drug: Carbetocin

Study Type: Interventional
Study Design: Allocation: 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 Delivery: A Dose Finding Study (Part 2)

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).


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: 120
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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
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: 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
  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: Dr. Jose C.A. Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01428817     History of Changes
Other Study ID Numbers: 11-02
Study First Received: September 1, 2011
Last Updated: March 23, 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
Obstetric Labor Complications
Pathologic Processes
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Carbetocin
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014