Carbetocin at Elective Cesarean Delivery Part 4

NCT02264769 | Completed

• 1 other identifier: 14-03
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Hemorrhage

Keywords

pregnancy; postpartum hemorrhage; Cesarean delivery; carbetocin

Outcome Measures

Primary Outcomes (1)

• Uterine tone

  Uterine tone on a scale of 0-10 at 2 minutes after completion of injection of carbetocin.

  2 minutes

Secondary Outcomes (4)

• Uterine tone

  5 minutes

• Additional uterotonic medication administration

  24 hours

• Blood loss

  48 hours

• Side Effects

  2 hours

Study Arms (2)

Carbetocin 20mcg

ACTIVE COMPARATOR

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

Drug: Carbetocin

Carbetocin 100mcg

ACTIVE COMPARATOR

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

Drug: Carbetocin

Interventions

Carbetocin DRUG

Also known as: Duratocin

Carbetocin 100mcg; Carbetocin 20mcg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Elective cesarean delivery under spinal anesthesia.
• Written informed consent to participate in this study.
• Term pregnancy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 15, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

CA (1)