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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Maisonneuve-Rosemont Hospital.
Recruitment status was:  Recruiting
Université de Montréal
Information provided by (Responsible Party):
Christian Loubert, Maisonneuve-Rosemont Hospital Identifier:
First received: April 13, 2012
Last updated: February 12, 2013
Last verified: February 2013
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: 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 ]
    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 ]
    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 ]
    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 ]
  • Additional uterotonic medication administered [ Time Frame: 20 minutes ]
  • Additional uterine massage [ Time Frame: 20 minutes ]

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01579201

Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Université de Montréal
Principal Investigator: Christian Loubert, MD, FRCPC Maisonneuve-Rosemont Hospital
  More Information

Responsible Party: Christian Loubert, Christian Loubert, MD, FRCPC, Maisonneuve-Rosemont Hospital Identifier: NCT01579201     History of Changes
Other Study ID Numbers: LoubertHMR2012/01 
Study First Received: April 13, 2012
Last Updated: February 12, 2013

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

Additional relevant MeSH terms:
Postpartum Hemorrhage
Uterine Inertia
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Reproductive Control Agents
Physiological Effects of Drugs processed this record on February 20, 2017