NCT01630187

Brief Summary

The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

3 months

First QC Date

May 17, 2012

Last Update Submit

May 27, 2013

Conditions

Uterine AtonyPost-partum Hemorrhage

Keywords

CarbetocinUterotonic drugelective cesarean section

Outcome Measures

Primary Outcomes (1)

  • Utilization of a second uterotonic drug

    First 48 hours of the postpartum

Secondary Outcomes (3)

  • Incidence of side effects

    During the fifteen minutes following the administration of carbetocin

  • Incidence of major complications

    First 48 hours of the postpartum

  • Drop in hemoglobin measurement

    on the second post-partum day

Study Arms (2)

Carbetocin 100 mcg

ACTIVE COMPARATOR
Drug: Carbetocin

Carbetocin 50 mcg

EXPERIMENTAL
Drug: Carbetocin

Interventions

CarbetocinDRUG

Administration of carbetocin 50 mcg , after clamping the umbilical cord

Carbetocin 50 mcg

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years old
  • ≥ 37-week pregnancy
  • singleton pregnancy
  • elective cesarean section with a low transverse incision
  • ASA I or II

You may not qualify if:

  • Personal history of uterine atony or postpartum hemorrhage
  • Abnormal placental implantation (known or suspected)
  • \> 3 cesarean sections in the past
  • Personal history of a classic uterine incision
  • Estimated fetal weight \> 4500g
  • Hemoglobin \< 100 g/L
  • Regular use of tocolytic drugs
  • Cesarean section under general anesthesia
  • Known allergy to carbetocin
  • Refusal
  • Inability to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint-François-d'Assise (CHUQ)

Québec, Quebec, G1L 3L5, Canada

Location

MeSH Terms

Conditions

Uterine InertiaPostpartum Hemorrhage

Interventions

carbetocin

Condition Hierarchy (Ancestors)

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

Study Officials

  • Julie Bédard

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
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

May 17, 2012

First Posted

June 28, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

CA(1)