Postpartum Hemorrhage Clinical Trial
Official title:
ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery
The purpose of this trial is to determine the effective dose of carbetocin which would prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective cesarean delivery.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Healthy pregnant women (ASA I or II) - Elective cesarean delivery - Spinal anesthesia - Term gestation (37 weeks and above) Exclusion Criteria: - Multiple gestation - Known coagulopathy - Active labour - Uterine fibroids - Body mass index > 45 - Emergency cesarean section - General anesthesia - Any contraindication to neuraxial anesthesia - Cardiopathies - Known allergies to carbetocin - Patient refusal - Placenta previa/Placenta accreta - Hypertensive disease/Preeclampsia/Eclampsia - Polyhydramnios - Previous history of uterine atony or postpartum hemorrhage - Renal or liver disease |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Maisonneuve-Rosemont Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Maisonneuve-Rosemont Hospital | Université de Montréal |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose of carbetocin which will prevent uterine atony in 90% of subjects | The uterine tone will be assessed by the obstetrician by palpation 5 minutes after injection. The uterine tone will be judged either as satisfactory or unsatisfactory. | 5 minutes | Yes |
Secondary | Incidence of side effects | Any of these side effects will be noted in the first 20 minutes following injection of carbetocin: hypotension, tachycardia, nausea, vomiting, flushing, headache, feeling of warmth, tremor, metallic taste, abdominal pain, back pain, chest pain and others. | 20 minutes | No |
Secondary | Vasopressors administered | The total dose of vasopressors administered in the first 20 minutes following the administration of carbetocin will be noted. | 20 minutes | No |
Secondary | Anti nausea therapy | 20 minutes | No | |
Secondary | Additional uterotonic medication administered | 20 minutes | Yes | |
Secondary | Additional uterine massage | 20 minutes | Yes |
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