Carbetocin at Elective Cesarean Delivery Part 4

Carbetocin at Elective Cesarean Deliveries: A Non-inferiority Study Between 20 and 100 Micrograms - Part 4

Patrocinadores

Patrocinador principal: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Fuente Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Resumen breve

PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH in North America. However oxytocin has a very short duration of action, requiring a continuous infusion to achieve sustained uterotonic activity. Moreover large doses are associated with adverse effects like hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery to promote uterine contraction. In three studies recently performed at Mount Sinai Hospital, the investigators have found no difference in uterine contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus a larger trial comparing the minimum effective dose determined in the previous three trials with the standard 100 mcg dose is necessary to confirm these findings.

Descripción detallada

The current oxytocin regimen requires the administration of a continuous infusion to achieve sustained uterotonic activity, which can be associated with a number of side effects and unpredictable efficacy. Carbetocin in a single 100 mcg dose has apparently greater efficacy, with a similar side effect profile to that of oxytocin. In addition, some studies have also shown that there is less blood loss and less requirement for additional uterotonic drugs when carbetocin is administered. Studies conducted by the investigators group at Mount Sinai have shown similar efficacy between the doses ranging from 20 to 100 mcg of carbetocin. In the investigators study, the investigators are going to compare those two doses of carbetocin to determine that 20 mcg is not inferior to 100 mcg to produce adequate uterine tone in elective cesarean delivery. This study will be a randomized, double - blind, non inferiority study.

Estado general Completed
Fecha de inicio October 2014
Fecha de Terminación May 2015
Fecha de finalización primaria April 2015
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Uterine tone 2 minutes
Resultado secundario
Medida Periodo de tiempo
Uterine tone 5 minutes
Additional uterotonic medication administration 24 hours
Blood loss 48 hours
Side Effects 2 hours
Inscripción 110
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Carbetocin

Otro nombre: Duratocin

Elegibilidad

Criterios:

Inclusion Criteria:

- Elective cesarean delivery under spinal anesthesia.

- Written informed consent to participate in this study.

- Term pregnancy

Exclusion Criteria:

- Refusal to give written informed consent.

- Allergy or hypersensitivity to carbetocin or oxytocin.

- 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.

- Hepatic, renal, and vascular disease.

Género: Female

Edad mínima: 18 Years

Edad máxima: 50 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Jose Carvalho, MD Principal Investigator MOUNT SINAI HOSPITAL
Ubicación
Instalaciones: Mount Sinai Hospital
Ubicacion Paises

Canada

Fecha de verificación

May 2015

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Carbetocin 20mcg

Tipo: Active Comparator

Descripción: Patient is given carbetocin 20 mcg intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.

Etiqueta: Carbetocin 100mcg

Tipo: Active Comparator

Descripción: Patient is given carbetocin 100 mcg intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov