Carbetocin Versus Syntometrine for the Third Stage of Labour

This study has been completed.
Sponsor:
Collaborator:
National Healthcare Group, Singapore
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00499005
First received: July 9, 2007
Last updated: September 18, 2009
Last verified: September 2009

July 9, 2007
September 18, 2009
November 2006
April 2009   (final data collection date for primary outcome measure)
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 [ Time Frame: Within 2 hours after delivery ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Within 2 hours after delivery ]
Complete list of historical versions of study NCT00499005 on ClinicalTrials.gov Archive Site
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 [ Time Frame: Within 2 hours after delivery ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Within 2 hours after delivery ]
Not Provided
Not Provided
 
Carbetocin Versus Syntometrine for the Third Stage of Labour
Carbetocin Versus Syntometrine for the Third Stage of Labour Following Vaginal Delivery - A Double-blind Randomised Trial

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

Postpartum haemorrhage(PPH)or excessive bleeding at or after childbirth is a potentially life threatening complication and is one of the major contributors to maternal mortality and morbidity worldwide (Lewis 2001).Among the various agents that have been studied in addition to the routine oxytocin and syntometrine (which has adverse effects),oxytocin agonist (carbetocin) appears to be the most promising for this indication(Chong 2004).

Carbetocin is a licensed medication for the use of prevention of postpartum haemorrhage in Singapore and many other countries. It is a long-acting synthetic octapeptide analogue of oxytocin with agonist properties.The clinical and pharmacological properties of carbetocin are similar to those of naturally occurring oxytocin. Like oxytocin, carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions, and increased uterine tone. In pharmacokinetic studies, intravenous injections of carbetocin produced tetanic uterine contractions within two minutes, lasting six minutes, followed by rhythmic contractions for a further hour.Intramuscular injection produced tetanic contractions in less than two minutes, lasting about 11 minutes, and followed by rhythmic contractions for an additional two hours. The prolonged duration of activity after intramuscular compared with the intravenous carbetocin was significant(Hunter 1992). In comparison to oxytocin, carbetocin induces a prolonged uterine response when administered postpartum, in terms of both amplitude and frequency of contractions.

The potential advantage of intramuscular carbetocin over intramuscular oxytocin is its longer duration of action. Its relative lack of gastrointestinal and cardiovascular side-effects should also prove advantageous compared to syntometrine and other ergot alkaloids.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Postpartum Haemorrhage
  • Drug: Syntommetrine and Carbetocin
    Syntommetrine 1ml and Carbetocin 100microgram
  • Drug: Syntommetrine and Carbetocin
    Syntommetrine 1ml and Carbetocin 100micgrams
  • Active Comparator: Primi
    Interventions:
    • Drug: Syntommetrine and Carbetocin
    • Drug: Syntommetrine and Carbetocin
  • Active Comparator: Multi
    Interventions:
    • Drug: Syntommetrine and Carbetocin
    • Drug: Syntommetrine and Carbetocin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
720
July 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Any pregnant woman expected to deliver vaginally
  2. Age more than 21 if not married
  3. Ability to provide informed consent

Exclusion Criteria:

  1. Multiple pregnancy
  2. Patients with other risk factors for postpartum haemorrhage
  3. Patients planning to have an elective caesarean section
  4. History of vascular disease such as coronary artery disease
  5. History of hypertension requiring treatment within the last 2 years
  6. History of hepatic or renal disease
  7. Known or suspected coagulopathy
  8. History of hypersensitivity to oxytocin or carbetocin
  9. Any condition where the use of syntometrine/carbetocin is contraindicated
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00499005
DSRB Ref: D/04/209, NHG-SIG/07059
Yes
Chong Yap Seng, MBBS, National HealthCare Group, Singapore
National University Hospital, Singapore
National Healthcare Group, Singapore
Principal Investigator: Su Lin Lin, MBBS National University Hospital, Singapore
National University Hospital, Singapore
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP