Carbetocin at Elective Cesarean Delivery Part 2

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-12-31

Brief Summary

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Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.

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Detailed Description

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The Society of Obstetricians and Gynecologists of Canada (SOGC) recently recommended a 100mcg intravenous bolus dose of carbetocin following Cesarean delivery.

Studies thus far show that carbetocin may be just as effective as oxytocin in promoting uterine contraction, with a similar side effect profile. In addition, patients receiving carbetocin may experience less blood loss, and require less additional uterotonics when compared with oxytocin. A dose response study conducted by Cordovani et al suggested no difference in efficacy of uterine contraction for doses of carbetocin between 80-120mcg. Additionally, hypotension was noted for all dose groups studied.

The results of this follow-up study will define the minimum required dose of carbetocin for uterine contraction, thus minimizing unnecessary side effects, improving quality and safety of patient care. It may also contribute in establishing carbetocin as a substitute to oxytocin for elective cesarean section at our institution as well as others.

Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Carbetocin 20mcg

Group Type ACTIVE_COMPARATOR

Carbetocin

Intervention Type DRUG

20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Carbetocin 40mcg

Group Type ACTIVE_COMPARATOR

Carbetocin

Intervention Type DRUG

40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Carbetocin 60mcg

Group Type ACTIVE_COMPARATOR

Carbetocin

Intervention Type DRUG

60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Carbetocin 80mcg

Group Type ACTIVE_COMPARATOR

Carbetocin

Intervention Type DRUG

80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Carbetocin 100mcg

Group Type ACTIVE_COMPARATOR

Carbetocin

Intervention Type DRUG

100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Interventions

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Carbetocin

20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Intervention Type DRUG

Carbetocin

40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Intervention Type DRUG

Carbetocin

60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Intervention Type DRUG

Carbetocin

80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Intervention Type DRUG

Carbetocin

100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Intervention Type DRUG

Other Intervention Names

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Duratocin Duratocin Duratocin Duratocin Duratocin

Eligibility Criteria

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Inclusion Criteria

* All patients planned for elective cesarean delivery under spinal anesthesia.
* All patients who give written informed consent to participate in this study.

Exclusion Criteria

* All patients who refuse to give written informed consent.
* All patients who claim allergy or hypersensitivity to carbetocin or oxytocin.
* All patients with 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.
* All patients with hepatic, renal, and vascular disease,
* All patients requiring general anesthesia prior to the administration of the study drug.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes