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CompletedNCT01630187Updated May 29, 2013

Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section

A Phase 4 interventional study of Carbetocin and Carbetocin in Uterine Atony and Post-partum Hemorrhage, sponsored by Laval University. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-29.

Sponsored by Laval University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

Postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony. To prevent this complication, uterotonic medication is used during elective cesarean section.

Carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years. This medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc. Using a smaller dose of carbetocin might lower the incidence of these side effects, without compromising prevention of uterine atony in a low-risk group of patient.

02

Conditions studied

  • Uterine Atony
  • Post-partum Hemorrhage

Keywords

  • Carbetocin
  • Uterotonic drug
  • elective cesarean section
03

In context

Postpartum Hemorrhage

445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.

This study's enrollment of 72 is below the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    Carbetocin 100 mcg

    Drug: Carbetocin

  • Experimental
    Carbetocin 50 mcg

    Drug: Carbetocin

Interventions

  • DrugCarbetocin

    Administration of carbetocin 50 mcg , after clamping the umbilical cord

  • DrugCarbetocin

    Administration of carbetocin 100 mcg , after clamping the umbilical cord

06

What researchers measure

Primary outcomes

  1. Utilization of a second uterotonic drug

    Time frame: First 48 hours of the postpartum

Secondary outcomes

  1. Incidence of side effects

    Time frame: During the fifteen minutes following the administration of carbetocin

  2. Incidence of major complications

    Time frame: First 48 hours of the postpartum

  3. Drop in hemoglobin measurement

    Time frame: on the second post-partum day

07

Study locations

1 site
  • Hôpital Saint-François-d'Assise (CHUQ)
    Quebec, G1L 3L5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01630187
Lead sponsor
Laval University
Responsible party
Sponsor
First posted
Jun 28, 2012
Start date
Apr 2012
Primary completion
Jul 2012
Completion
Jul 2012
Last update
May 29, 2013

Study contacts

Julie Bédard
principal investigator · Laval University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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