Randomized controlled trial comparing the effect of carbetocin vs syntocinon and ergometrine on postpartum haemorrhage in patients undergoing elective caesarean section - C.A.S.E. Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002341-20-GB

Enrollment

600

Registered

2008-05-16

Start date

2008-07-10

Completion date

Unknown

Last updated

2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical efficacy comparing ( 2 drugs) carbetocin Vs syntocinon and ergometrine

Interventions

Product Name: carbetocin Pharmaceutical Form: Injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Full consent from patient, over 18 years of age Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Hypersensitivity to carbetocin or oxytocin, hepatic or renal disease, vascular disease, severe cardiac disease, impaired pulmonary function, sepsis, severe hypertension, pre-eclampsia or eclampsia, contraindications to ergometrine (previous hypersensitivity or idiosyncratic reactions to ergometrine or other ergot alkaloids, current use of doxycycline, tetracycline, sumatriptan, dopamine or methysergide, postpartum use of bromocriptine), general anaesthesia, Patients on erythromycin will be excluded as ergot toxicity can develop rapidly in patients on ergotamine.

Design outcomes

Primary

Measure	Time frame
Main Objective: Is to ascertain whether carbetocin is more effective in reducing bleeding after the delivery of the baby during a planned ceasarean section compared with the current management which uses syntocinon and ergometrine. ;Secondary Objective: To compare the side effects of the drugs between the 2 treatment arms;Primary end point(s): The main outcome measure will be our primary outcome and will be evaluated by recording clinical interventions required to control bleeding. These interventions are listed below. 1. Blood transfusion 2. Syntocinon infusion 3. Haemabate administration 4. Physical methods such as insertion of uterine (Rusch) balloon and manual uterine massage The patient will fill in a questionnaire regarding the side effects after the procedure.	—

Measure

Time frame

Main Objective: Is to ascertain whether carbetocin is more effective in reducing bleeding after the delivery of the baby during a planned ceasarean section compared with the current management which uses syntocinon and ergometrine. ;Secondary Objective: To compare the side effects of the drugs between the 2 treatment arms;Primary end point(s): The main outcome measure will be our primary outcome and will be evaluated by recording clinical interventions required to control bleeding. These interventions are listed below. 1. Blood transfusion 2. Syntocinon infusion 3. Haemabate administration 4. Physical methods such as insertion of uterine (Rusch) balloon and manual uterine massage The patient will fill in a questionnaire regarding the side effects after the procedure.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026