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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
History of Changes
  Purpose

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


Condition Intervention Phase
Postpartum Haemorrhage
 Drug: Syntommetrine and Carbetocin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Carbetocin Versus Syntometrine for the Third Stage of Labour Following Vaginal Delivery - A Double-blind Randomised Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 720
Study Start Date: November 2006
Study Completion Date: July 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Primi Drug: Syntommetrine and Carbetocin
Syntommetrine 1ml and Carbetocin 100microgram
Drug: Syntommetrine and Carbetocin
Syntommetrine 1ml and Carbetocin 100micgrams
Active Comparator: Multi Drug: Syntommetrine and Carbetocin
Syntommetrine 1ml and Carbetocin 100microgram
Drug: Syntommetrine and Carbetocin
Syntommetrine 1ml and Carbetocin 100micgrams

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499005

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
National Healthcare Group, Singapore
Investigators
Principal Investigator: Su Lin Lin, MBBS National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: Chong Yap Seng, MBBS, National HealthCare Group, Singapore
ClinicalTrials.gov Identifier: NCT00499005     History of Changes
Other Study ID Numbers: DSRB Ref: D/04/209, NHG-SIG/07059
Study First Received: July 9, 2007
Last Updated: September 18, 2009
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Carbetocin
 Oxytocin
Syntometrine
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013