Carbetocin Versus Syntometrine for the Third Stage of Labour

Postpartum Haemorrhage Clinical Trial

Official title:

Carbetocin Versus Syntometrine for the Third Stage of Labour Following Vaginal Delivery - A Double-blind Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499005
• Other study ID #: DSRB Ref: D/04/209
• Secondary ID: NHG-SIG/07059
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2007
• Last updated: September 18, 2009
• Start date: November 2006
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: July 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Postpartum Haemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Syntommetrine and Carbetocin
Syntommetrine 1ml and Carbetocin 100microgram
• Syntommetrine and Carbetocin
Syntommetrine 1ml and Carbetocin 100micgrams

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National Healthcare Group, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes