E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Clinical efficacy comparing ( 2 drugs) carbetocin Vs syntocinon and ergometrine |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To compare the side effects of the drugs between the 2 treatment arms |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Full consent from patient, over 18 years of age |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial is 600th patient/2year period/if any adverse reactions happened which endangered patient safety. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |