ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery
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|ClinicalTrials.gov Identifier: NCT01579201|
Recruitment Status : Unknown
Verified February 2013 by Christian Loubert, Maisonneuve-Rosemont Hospital.
Recruitment status was: Recruiting
First Posted : April 17, 2012
Last Update Posted : February 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage Uterine Atony||Drug: Carbetocin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||March 2013|
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
- Dose of carbetocin which will prevent uterine atony in 90% of subjects [ Time Frame: 5 minutes ]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 ]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 ]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 ]
- Additional uterotonic medication administered [ Time Frame: 20 minutes ]
- Additional uterine massage [ Time Frame: 20 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579201
|Contact: Christian Loubert, MD, FRCPCfirstname.lastname@example.org|
|Contact: Louis-Philippe Fortier, MD, FRCPCemail@example.com|
|Montreal, Quebec, Canada, H1T 2M4|
|Contact: Christian Loubert, MD, FRCPC 514.252.3426 firstname.lastname@example.org|
|Contact: Louis-Philippe Fortier, MD, FRCPC 514.252.3426 email@example.com|
|Principal Investigator: Christian Loubert, MD, FRCPC|
|Sub-Investigator: Patrick Coursol-Provost, MD|
|Sub-Investigator: Louis-Philippe Fortier, MD, FRCPC|
|Sub-Investigator: Pierre Drolet, MD, FRCPC|
|Principal Investigator:||Christian Loubert, MD, FRCPC||Maisonneuve-Rosemont Hospital|