ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery

Conditions
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Postpartum Hemorrhage, Uterine Atony

Intervention / Treatment
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* Drug: Carbetocin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbetocin<br> | Drug: Carbetocin<br>* 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.<br>* Other names: Duratocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Vasopressors administered | The total dose of vasopressors administered in the first 20 minutes following the administration of carbetocin will be noted. | 20 minutes | 
| Anti nausea therapy |  | 20 minutes | 
| Additional uterotonic medication administered |  | 20 minutes | 
| Additional uterine massage |  | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Hemorrhage, Uterine Atony, Obstetric Anesthesia, Cesarean Section, Carbetocin