NCT01262742

Brief Summary

Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly 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. We hypothesize that a dose-response study will establish the minimum dose of carbetocin required to produce appropriate contractility in 95% of the women (ED95) undergoing elective cesarean delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2010

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

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 25, 2025

Status Verified

September 1, 2011

Enrollment Period

4 months

First QC Date

December 16, 2010

Last Update Submit

April 22, 2025

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 80mcg

ACTIVE COMPARATOR
Drug: Carbetocin

Carbetocin 90mcg

ACTIVE COMPARATOR
Drug: Carbetocin

Carbetocin 100mcg

ACTIVE COMPARATOR
Drug: Carbetocin

Carbetocin 110mcg

ACTIVE COMPARATOR
Drug: Carbetocin

Carbetocin 120mcg

ACTIVE COMPARATOR
Drug: Carbetocin

Interventions

CarbetocinDRUG

80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Also known as: Duratocin
Carbetocin 80mcg

Eligibility Criteria

Age18 Years - 50 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 gave 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)

  • Cordovani D, Balki M, Farine D, Seaward G, Carvalho JC. Carbetocin at elective Cesarean delivery: a randomized controlled trial to determine the effective dose. Can J Anaesth. 2012 Aug;59(8):751-7. doi: 10.1007/s12630-012-9728-2. Epub 2012 Jun 21.

    PMID: 22717890DERIVED

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2010

First Posted

December 17, 2010

Study Start

November 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

April 25, 2025

Record last verified: 2011-09

Locations

CA(1)