ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Maisonneuve-Rosemont Hospital
Sponsor:
Collaborator:
Université de Montréal
Information provided by (Responsible Party):
Christian Loubert, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:
NCT01579201
First received: April 13, 2012
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

The purpose of this trial is to determine the effective dose of carbetocin which would prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective cesarean delivery.


Condition Intervention Phase
Postpartum Hemorrhage
Uterine Atony
Drug: Carbetocin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by Maisonneuve-Rosemont Hospital:

Primary Outcome Measures:
  • Dose of carbetocin which will prevent uterine atony in 90% of subjects [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]
    The uterine tone will be assessed by the obstetrician by palpation 5 minutes after injection. The uterine tone will be judged either as satisfactory or unsatisfactory.


Secondary Outcome Measures:
  • Incidence of side effects [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    Any of these side effects will be noted in the first 20 minutes following injection of carbetocin: hypotension, tachycardia, nausea, vomiting, flushing, headache, feeling of warmth, tremor, metallic taste, abdominal pain, back pain, chest pain and others.

  • Vasopressors administered [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    The total dose of vasopressors administered in the first 20 minutes following the administration of carbetocin will be noted.

  • Anti nausea therapy [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
  • Additional uterotonic medication administered [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]
  • Additional uterine massage [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carbetocin Drug: Carbetocin
First patient: 70 mcg. Following doses according to biased coin design up-down sequential allocation method, with increments or decrements of 10 mcg. An unsatisfactory uterine tone will lead to an increment while a satisfactory uterine tone will result in either a decrement or no change.
Other Name: Duratocin

Detailed Description:

Postpartum hemorrhage is a major cause of maternal morbidity and mortality worldwide. Carbetocin have been shown effective in the prevention of uterine atony, which is the leading cause of postpartum hemorrhage. The Society of Obstetricians and Gynecologists of Canada recommends a single 100 mcg dose of carbetocin after elective cesarean delivery to prevent postpartum hemorrhage. However, there is no clear data in the literature regarding the lowest effective dose of carbetocin that should be administered. The use of the minimum effective dose of carbetocin may reduce its side effects, including hypotension, tachycardia, nausea, vomiting and flushing.

In this trial, healthy term pregnant women undergoing elective cesarean delivery under spinal anesthesia will be recruited. The effective dose of carbetocin that will prevent postpartum uterine atony in 90% of the women (ED90) will be determined using a biased coin design up-down sequential allocation method. The determination of the carbetocin ED90 will help the anesthesiologist regarding the optimal dose of carbetocin to administer after elective cesarean delivery to prevent uterine atony.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy pregnant women (ASA I or II)
  • Elective cesarean delivery
  • Spinal anesthesia
  • Term gestation (37 weeks and above)

Exclusion Criteria:

  • Multiple gestation
  • Known coagulopathy
  • Active labour
  • Uterine fibroids
  • Body mass index > 45
  • Emergency cesarean section
  • General anesthesia
  • Any contraindication to neuraxial anesthesia
  • Cardiopathies
  • Known allergies to carbetocin
  • Patient refusal
  • Placenta previa/Placenta accreta
  • Hypertensive disease/Preeclampsia/Eclampsia
  • Polyhydramnios
  • Previous history of uterine atony or postpartum hemorrhage
  • Renal or liver disease
  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: NCT01579201

Contacts
Contact: Christian Loubert, MD, FRCPC 514.252.3426 loubertch@yahoo.fr
Contact: Louis-Philippe Fortier, MD, FRCPC 514.252.3426 lpfortier@mac.com

Locations
Canada, Quebec
Maisonneuve-Rosemont Hospital Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Christian Loubert, MD, FRCPC    514.252.3426    loubertch@yahoo.fr   
Contact: Louis-Philippe Fortier, MD, FRCPC    514.252.3426    lpfortier@mac.com   
Principal Investigator: Christian Loubert, MD, FRCPC         
Sub-Investigator: Patrick Coursol-Provost, MD         
Sub-Investigator: Louis-Philippe Fortier, MD, FRCPC         
Sub-Investigator: Pierre Drolet, MD, FRCPC         
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Université de Montréal
Investigators
Principal Investigator: Christian Loubert, MD, FRCPC Maisonneuve-Rosemont Hospital
  More Information

No publications provided

Responsible Party: Christian Loubert, Christian Loubert, MD, FRCPC, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT01579201     History of Changes
Other Study ID Numbers: LoubertHMR2012/01
Study First Received: April 13, 2012
Last Updated: February 12, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Maisonneuve-Rosemont Hospital:
Postpartum Hemorrhage
Uterine Atony
Obstetric Anesthesia
Cesarean Section
Carbetocin

Additional relevant MeSH terms:
Puerperal Disorders
Hemorrhage
Postpartum Hemorrhage
Uterine Inertia
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Uterine Hemorrhage
Dystocia
Carbetocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014