Carbetocin at Cesarean Delivery for Labor Arrest

NCT01725243 | Completed

• 1 other identifier: 12-07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In 2009, the Society of Obstetricians and Gynecologists Canada, which produces national clinical guidelines on important women's health issues, recommended that a bolus of carbetocin 100 mcg into your vein should be used at elective cesarean delivery instead of oxytocin infusion for the prevention of bleeding after you deliver your baby. Similar to oxytocin, carbetocin has side effects that are dose-related. Although 100 mcg has been the recommend dose, studies in nonlaboring women suggest that doses lower than 100 mcg may be used to achieve the same degree of uterine contractility with less side effects. So far, the ideal dose to be used in cesarean sections for labouring women who have failure to progress in labour (failure of your cervix to dilate adequately to 10cm or the baby's head not descending the birth canal) has not been determined. This study is designed to determine the minimum carbetocin dose required during cesarean delivery for 'failure to progress' to achieve the best effect.

Conditions

Postpartum Hemorrhage

Keywords

pregnancy; postpartum hemorrhage; Cesarean delivery; carbetocin; failure to progress in labor

Outcome Measures

Primary Outcomes (1)

• need for additional uterotonics

  need for additional uterotonics in the OR at the time of cesarean section based upon the assessment of unsatisfactory/indeterminate uterine tone in response to the single bolus of carbetocin.

  30 minutes

Secondary Outcomes (5)

• uterine tone

  10 minutes

• uterine tone

  2 hours

• need for additional uterotonic

  24 hours

• Blood loss

  24 hours

• side effects

  2 hours

Study Arms (8)

Carbetocin 10mcg

ACTIVE COMPARATOR

Carbetocin 10mcg IV, once following delivery.

Drug: Carbetocin

Carbetocin 20mcg

ACTIVE COMPARATOR

Carbetocin 20mcg IV, once following delivery.

Drug: Carbetocin

Carbetocin 40mcg

ACTIVE COMPARATOR

Carbetocin 40mcg IV, once following delivery.

Drug: Carbetocin

Carbetocin 60mcg

ACTIVE COMPARATOR

Carbetocin 60mcg IV, once following delivery.

Drug: Carbetocin

Carbetocin 80mcg

ACTIVE COMPARATOR

Carbetocin 80mcg IV, once following delivery.

Drug: Carbetocin

Carbetocin 100mcg

ACTIVE COMPARATOR

Carbetocin 100mcg IV, once following delivery.

Drug: Carbetocin

Carbetocin 120mcg

ACTIVE COMPARATOR

Carbetocin 120mcg IV, once following delivery.

Drug: Carbetocin

Carbetocin 140mcg

ACTIVE COMPARATOR

Carbetocin 140mcg IV, once following delivery.

Drug: Carbetocin

Interventions

Carbetocin DRUG

Carbetocin IV, over 1 minute following delivery. Doses: 10, 20, 40, 60, 80, 100, 120 or 140mcg

Also known as: Duratocin

Carbetocin 100mcg; Carbetocin 10mcg; Carbetocin 120mcg; Carbetocin 140mcg; Carbetocin 20mcg; Carbetocin 40mcg; Carbetocin 60mcg; Carbetocin 80mcg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All patients who have given written informed consent to participate in this study.
• All patients planned for uncomplicated low transverse cesarean delivery secondary to labor arrest, under epidural anesthesia.
• ≥37 week pregnancy
• Singleton pregnancy
• Patients who have received oxytocin for at least 4 hours for labor augmentation
• ASA 1 or 2

You may not qualify if:

• Refusal or inability to obtain informed consent.
• All patients who claim allergy or hypersensitivity to oxytocin and carbetocin.
• Previous history of uterine atony or PPH
• Risk factors for PPH such as pre-eclampsia, polyhydramnios, uterine fibroids, bleeding diathesis and chorioamnionitis etc.
• Abnormal placental implantation (known or suspected)
• \> 3 cesarean sections in the past
• Previous classic uterine incision
• Macrosomia - Estimated fetal weight \> 4500g
• Hemoglobin \< 100g/L
• Cesarean section under general anesthesia
• ASA 3 and 4 or patients with hepatic, renal, cardiac (eg. Coronary artery disease) and vascular disease
• Genital development problems (eg. Abnormal uterus, cervix, vagina, etc.)
• Uncontrolled hypotension or hypertension
• Uncontrolled diabetes
• Abnormal heart rhythms and bradycardia

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• Nguyen-Lu N, Carvalho JC, Farine D, Seaward G, Ye XY, Balki M. Carbetocin at Cesarean delivery for labour arrest: a sequential allocation trial to determine the effective dose. Can J Anaesth. 2015 Aug;62(8):866-74. doi: 10.1007/s12630-015-0375-2. Epub 2015 Apr 10.

  PMID: 25860126 DERIVED

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

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON 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: November 8, 2012
• First Posted: November 12, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

CA (1)