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
- Conditions
- Clinical efficacy comparing ( 2 drugs) carbetocin Vs syntocinon and ergometrine
- Registration Number
- EUCTR2007-002341-20-GB
- Lead Sponsor
- Queen Charlotte's and Chelsea Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 600
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br> <br>1. Blood transfusion<br>2. Syntocinon infusion<br>3. Haemabate administration<br>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.<br>
- Secondary Outcome Measures
Name Time Method