NCT01651130

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 study to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is at least 20mcgs (or perhaps below) in women undergoing elective Cesarean delivery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

2 months

First QC Date

July 24, 2012

Last Update Submit

May 28, 2013

Conditions

Postpartum Hemorrhage

Keywords

pregnancypostpartum hemorrhageCesarean deliverycarbetocin

Outcome Measures

Primary Outcomes (1)

  • Uterine tone

    The obstetrician will assess uterine tone by palpation. Uterine tone will be rated as satisfactory (firm) or unsatisfactory (boggy). Unsatisfactory uterine tone will be treated with oxytocin as per the obstetrician.

    2 minutes

Secondary Outcomes (3)

  • Uterine tone

    2 hours

  • Blood loss

    48 hours

  • Side effects

    2 hours

Study Arms (6)

Carbetocin 100mcg

ACTIVE COMPARATOR

Carbetocin 100mcg, once following delivery of the fetal head.

Drug: Carbetocin

Carbetocin 20mcg

ACTIVE COMPARATOR

Carbetocin 20mcg, once following delivery of the fetal head.

Drug: Carbetocin

Carbetocin 15mcg

ACTIVE COMPARATOR

Carbetocin 15mcg, once following delivery of the fetal head.

Drug: Carbetocin

Carbetocin 10mcg

ACTIVE COMPARATOR

Carbetocin 10mcg, following delivery of the fetal head.

Drug: Carbetocin

Carbetocin 5mcg

ACTIVE COMPARATOR

Carbetocin 5mcg, following delivery of the fetal head.

Drug: Carbetocin

Carbetocin 2mcg

ACTIVE COMPARATOR

Carbetocin 2mcg, following delivery of the fetal head.

Drug: Carbetocin

Interventions

CarbetocinDRUG

Carbetocin IV, over 1 minute following delivery of the fetal head. Doses: 2, 5, 10, 15, 20 or 100mcg

Also known as: Duratocin
Carbetocin 100mcgCarbetocin 10mcgCarbetocin 15mcgCarbetocin 20mcgCarbetocin 2mcgCarbetocin 5mcg

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients planned for elective cesarean delivery under spinal anesthesia
  • Patients who give written informed consent to participate

You may not qualify if:

  • Patients who refuse to give written informed consent
  • Patients who claim allergy or hypersensitivity to carbetocin or oxytocin
  • 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.
  • Patients with hepatic, renal, and vascular disease
  • Patients requiring general anesthesia prior to the administration of the study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

  • Khan M, Balki M, Ahmed I, Farine D, Seaward G, Carvalho JC. Carbetocin at elective Cesarean delivery: a sequential allocation trial to determine the minimum effective dose. Can J Anaesth. 2014 Mar;61(3):242-8. doi: 10.1007/s12630-013-0082-9. Epub 2013 Nov 27.

    PMID: 24281981DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jose CA Carvalho, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2012

First Posted

July 26, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations

CA(1)