Carbetocin Versus Syntometrine for the Third Stage of Labour

NCT ID: NCT00499005

Last Updated: 2009-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2009-07-31

Brief Summary

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

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.

Conditions

Postpartum Haemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Primi

Group Type: ACTIVE_COMPARATOR

Syntommetrine and Carbetocin

Intervention Type: DRUG

Syntommetrine 1ml and Carbetocin 100microgram

Syntommetrine and Carbetocin

Intervention Type: DRUG

Syntommetrine 1ml and Carbetocin 100micgrams

Multi

Group Type: ACTIVE_COMPARATOR

Syntommetrine and Carbetocin

Intervention Type: DRUG

Syntommetrine 1ml and Carbetocin 100microgram

Syntommetrine and Carbetocin

Intervention Type: DRUG

Syntommetrine 1ml and Carbetocin 100micgrams

Interventions

Syntommetrine and Carbetocin

Syntommetrine 1ml and Carbetocin 100microgram

Intervention Type: DRUG

Syntommetrine and Carbetocin

Syntommetrine 1ml and Carbetocin 100micgrams

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Healthcare Group, Singapore

OTHER_GOV

Sponsor Role: collaborator

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

National HealthCare Group, Singapore

Principal Investigators

Su Lin Lin, MBBS

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

National University Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

NHG-SIG/07059

Identifier Type: -

Identifier Source: secondary_id

DSRB Ref: D/04/209

Identifier Type: -

Identifier Source: org_study_id