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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-03-31

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.

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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.

Conditions

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Postpartum Hemorrhage Uterine Atony

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Carbetocin

Group Type EXPERIMENTAL

Carbetocin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Duratocin

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No