NCT01428817

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

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, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

6 months

First QC Date

September 1, 2011

Last Update Submit

March 23, 2012

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).

    2 minutes

Secondary Outcomes (3)

  • Uterine tone

    2 hours

  • Blood loss

    48 hours

  • Side effects

    2 hours

Study Arms (5)

Carbetocin 20mcg

ACTIVE COMPARATOR
Drug: Carbetocin

Carbetocin 40mcg

ACTIVE COMPARATOR
Drug: Carbetocin

Carbetocin 60mcg

ACTIVE COMPARATOR
Drug: Carbetocin

Carbetocin 80mcg

ACTIVE COMPARATOR
Drug: Carbetocin

Carbetocin 100mcg

ACTIVE COMPARATOR
Drug: Carbetocin

Interventions

CarbetocinDRUG

20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Also known as: Duratocin
Carbetocin 20mcg

Eligibility Criteria

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

You may qualify if:

  • All patients planned for elective cesarean delivery under spinal anesthesia.
  • All patients who give written informed consent to participate in this study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

  • Anandakrishnan S, Balki M, Farine D, Seaward G, Carvalho JC. Carbetocin at elective Cesarean delivery: a randomized controlled trial to determine the effective dose, part 2. Can J Anaesth. 2013 Nov;60(11):1054-60. doi: 10.1007/s12630-013-0028-2. Epub 2013 Sep 25.

    PMID: 24158878DERIVED

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
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 5, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations

CA(1)