Carbetocin at Elective Cesarean Delivery Part 4
Keywords
Abstract
Description
The current oxytocin regimen requires the administration of a continuous infusion to achieve sustained uterotonic activity, which can be associated with a number of side effects and unpredictable efficacy. Carbetocin in a single 100 mcg dose has apparently greater efficacy, with a similar side effect profile to that of oxytocin. In addition, some studies have also shown that there is less blood loss and less requirement for additional uterotonic drugs when carbetocin is administered. Studies conducted by the investigators group at Mount Sinai have shown similar efficacy between the doses ranging from 20 to 100 mcg of carbetocin. In the investigators study, the investigators are going to compare those two doses of carbetocin to determine that 20 mcg is not inferior to 100 mcg to produce adequate uterine tone in elective cesarean delivery. This study will be a randomized, double - blind, non inferiority study.
Dates
Last Verified: | 04/30/2015 |
First Submitted: | 10/08/2014 |
Estimated Enrollment Submitted: | 10/13/2014 |
First Posted: | 10/14/2014 |
Last Update Submitted: | 05/21/2015 |
Last Update Posted: | 05/26/2015 |
Actual Study Start Date: | 09/30/2014 |
Estimated Primary Completion Date: | 03/31/2015 |
Estimated Study Completion Date: | 04/30/2015 |
Condition or disease
Intervention/treatment
Drug: Carbetocin
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Active Comparator: Carbetocin 20mcg Patient is given carbetocin 20 mcg intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby. | |
Active Comparator: Carbetocin 100mcg Patient is given carbetocin 100 mcg intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby. |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | Female |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - Elective cesarean delivery under spinal anesthesia. - Written informed consent to participate in this study. - Term pregnancy Exclusion Criteria: - Refusal to give written informed consent. - Allergy or hypersensitivity to carbetocin or oxytocin. - Conditions that predispose to uterine atony and postpartum hemorrhage, such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis. - Hepatic, renal, and vascular disease. |
Outcome
Primary Outcome Measures
1. Uterine tone [2 minutes]
Secondary Outcome Measures
1. Uterine tone [5 minutes]
2. Additional uterotonic medication administration [24 hours]
3. Blood loss [48 hours]
4. Side Effects [2 hours]