NCT00499005

Brief Summary

Intramuscular carbetocin is as effective as intramuscular syntometrine for the prevention of postpartum haemorrhage

Trial Health

87
On Track

Trial Health Score

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

Enrollment
720

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2006

Typical duration 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

November 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 21, 2009

Status Verified

September 1, 2009

Enrollment Period

2.4 years

First QC Date

July 9, 2007

Last Update Submit

September 18, 2009

Conditions

Postpartum Haemorrhage

Outcome Measures

Primary Outcomes (1)

  • 1. Postpartum haemorrhage (less than or equal to 500 ml) 2. Postpartum haemorrhage (less than or equal to 1000ml) 3. Use of additional uterotonic therapy

    Within 2 hours after delivery

Secondary Outcomes (1)

  • 1. Adverse effects with the intervention which include headache, nausea, vomiting, elevation of blood pressure and retained placenta 2. Cost effectiveness analysis of the intervention

    Within 2 hours after delivery

Study Arms (2)

Primi

ACTIVE COMPARATOR
Drug: Syntommetrine and Carbetocin

Multi

ACTIVE COMPARATOR
Drug: Syntommetrine and Carbetocin

Interventions

Syntommetrine and CarbetocinDRUG

Syntommetrine 1ml and Carbetocin 100microgram

MultiPrimi

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Any pregnant woman expected to deliver vaginally
  • Age more than 21 if not married
  • Ability to provide informed consent

You may not qualify if:

  • Multiple pregnancy
  • Patients with other risk factors for postpartum haemorrhage
  • Patients planning to have an elective caesarean section
  • History of vascular disease such as coronary artery disease
  • History of hypertension requiring treatment within the last 2 years
  • History of hepatic or renal disease
  • Known or suspected coagulopathy
  • History of hypersensitivity to oxytocin or carbetocin
  • Any condition where the use of syntometrine/carbetocin is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

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

  • Su Lin Lin, MBBS

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 11, 2007

Study Start

November 1, 2006

Primary Completion

April 1, 2009

Study Completion

July 1, 2009

Last Updated

September 21, 2009

Record last verified: 2009-09

Locations

SG(1)