ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postpartum Hemorrhage Uterine Atony |
Drug: Carbetocin |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 40 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Carbetocin |
Drug: Carbetocin
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
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Christian Loubert, MD, FRCPC | 514.252.3426 | loubertch@yahoo.fr |
| Contact: Louis-Philippe Fortier, MD, FRCPC | 514.252.3426 | lpfortier@mac.com |
| Canada, Quebec | |
| Maisonneuve-Rosemont Hospital | Recruiting |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Contact: Christian Loubert, MD, FRCPC 514.252.3426 loubertch@yahoo.fr | |
| Contact: Louis-Philippe Fortier, MD, FRCPC 514.252.3426 lpfortier@mac.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 |
More Information
No publications provided
| Responsible Party: | Christian Loubert, Christian Loubert, MD, FRCPC, Maisonneuve-Rosemont Hospital |
| ClinicalTrials.gov Identifier: | NCT01579201 History of Changes |
| Other Study ID Numbers: | LoubertHMR2012/01 |
| Study First Received: | April 13, 2012 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Maisonneuve-Rosemont Hospital:
|
Postpartum Hemorrhage Uterine Atony Obstetric Anesthesia Cesarean Section Carbetocin |
Additional relevant MeSH terms:
|
Hemorrhage Postpartum Hemorrhage Uterine Inertia Pathologic Processes Obstetric Labor Complications Pregnancy Complications Puerperal Disorders Uterine Hemorrhage |
Dystocia Carbetocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013