ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery
Recruitment status was: Recruiting
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery|
- Dose of carbetocin which will prevent uterine atony in 90% of subjects [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]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.
- Incidence of side effects [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]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.
- Vasopressors administered [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]The total dose of vasopressors administered in the first 20 minutes following the administration of carbetocin will be noted.
- Anti nausea therapy [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
- Additional uterotonic medication administered [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]
- Additional uterine massage [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
First patient: 70 mcg. Following doses according to biased coin design up-down sequential allocation method, with increments or decrements of 10 mcg. An unsatisfactory uterine tone will lead to an increment while a satisfactory uterine tone will result in either a decrement or no change.
Other Name: Duratocin
Postpartum hemorrhage is a major cause of maternal morbidity and mortality worldwide. Carbetocin have been shown effective in the prevention of uterine atony, which is the leading cause of postpartum hemorrhage. The Society of Obstetricians and Gynecologists of Canada recommends a single 100 mcg dose of carbetocin after elective cesarean delivery to prevent postpartum hemorrhage. However, there is no clear data in the literature regarding the lowest effective dose of carbetocin that should be administered. The use of the minimum effective dose of carbetocin may reduce its side effects, including hypotension, tachycardia, nausea, vomiting and flushing.
In this trial, healthy term pregnant women undergoing elective cesarean delivery under spinal anesthesia will be recruited. The effective dose of carbetocin that will prevent postpartum uterine atony in 90% of the women (ED90) will be determined using a biased coin design up-down sequential allocation method. The determination of the carbetocin ED90 will help the anesthesiologist regarding the optimal dose of carbetocin to administer after elective cesarean delivery to prevent uterine atony.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579201
|Montreal, Quebec, Canada, H1T 2M4|
|Principal Investigator:||Christian Loubert, MD, FRCPC||Maisonneuve-Rosemont Hospital|