Carbetocin Versus Syntometrine for the Third Stage of Labour

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00499005
Recruitment Status : Completed
First Posted : July 11, 2007
Last Update Posted : September 21, 2009
National Healthcare Group, Singapore
Information provided by:
National University Hospital, Singapore

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

Condition or disease Intervention/treatment Phase
Postpartum Haemorrhage Drug: Syntommetrine and Carbetocin Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Carbetocin Versus Syntometrine for the Third Stage of Labour Following Vaginal Delivery - A Double-blind Randomised Trial
Study Start Date : November 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 [ Time Frame: Within 2 hours after delivery ]

Secondary Outcome Measures :
  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 [ Time Frame: Within 2 hours after delivery ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00499005

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

Responsible Party: Chong Yap Seng, MBBS, National HealthCare Group, Singapore Identifier: NCT00499005     History of Changes
Other Study ID Numbers: DSRB Ref: D/04/209
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Reproductive Control Agents
Physiological Effects of Drugs