A study on carbetocin (Pabal®) versus oxytocin (Syntocinon®)
Completed
- Conditions
- Obstetrics / Caesarean sectionPregnancy and Childbirth
- Registration Number
- ISRCTN98070045
- Lead Sponsor
- Ferring B.V. (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 1500
Inclusion Criteria
Charts of women who have undergone elective CS under epidural and/or spinal anaesthesia and treated with carbetocin or oxytocin.
Exclusion Criteria
Contraindications, warnings, precautions and interactions with other drugs mentioned in the summary of product characteristics of carbetocin and oxytocin.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eed for additional uterotonic treatment during the first 24 hours after carbetocin or oxytocin administration.
- Secondary Outcome Measures
Name Time Method 1. Need for blood transfusion during the first 24 hours<br>2. Need for operative interventions other than the initial CS during the first 24 hours<br>3. Need for uterus massage during the first 24 hours<br>4. Change in haematocrit and haemoglobin post versus pre CS<br>5. Amount of intraoperative blood loss<br>6. Incidence of intraoperative blood loss > 500 ml<br>7. Incidence of intraoperative blood loss > 1000 ml<br>8. Position of fundus after wound closure (only in prospective part of the study)<br>9. Uterus tone after uterotonic treatment<br>10. Investigator?s subjective experience with oxytocin/carbetocin