Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2

NCT03672045 | Completed

• 1 other identifier: 18-07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality. Carbetocin is a uterotonic with a superior pharmacokinetic profile to oxytocin. In a study performed at Mount Sinai Hospital, the investigators have shown that smaller doses of carbetocin (14.8 mcg) are as effective in achieving adequate uterine tone at elective cesarean section compared to the current recommended dose of 100mcg. However, this study was limited to those women with a body mass index (BMI) of \<40 kg/m2. Maternal obesity has been shown to increase the risks of hemorrhage secondary to uterine atony, therefore the investigators wish to perform a dose finding study to determine the ED90 of carbetocin at caesarean section in those women with a BMI\>40.

Conditions

Postpartum Hemorrhage

Keywords

pregnancy; postpartum hemorrhage; Cesarean delivery; carbetocin

Outcome Measures

Primary Outcomes (1)

• Intraoperative requirement for additional uterotonic medication

  A request made by the obstetrician performing the cesarean delivery for additional uterotonic medication, due to bleeding or poor uterine tone.

  1 hour

Secondary Outcomes (17)

• Uterine tone 2 minutes

  2 minutes

• Uterine tone 5 minutes

  5 minutes

• Additional uterotonics administered

  45 minutes

• Estimated blood loss

  24 hours

• Intravenous fluid administered during surgery

  2 hours

Study Arms (6)

Carbetocin 10mcg

ACTIVE COMPARATOR

Patient is given 10 mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Drug: Carbetocin

Carbetocin 20mcg

ACTIVE COMPARATOR

Patient is given 20 mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Drug: Carbetocin

Carbetocin 40mcg

ACTIVE COMPARATOR

Patient is given 40 mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Drug: Carbetocin

Carbetocin 60mcg

ACTIVE COMPARATOR

Patient is given 60 mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Drug: Carbetocin

Carbetocin 80mcg

ACTIVE COMPARATOR

Patient is given 80 mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Drug: Carbetocin

Carbetocin 100mcg

ACTIVE COMPARATOR

Patient is given 100 mcg of carbetocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Drug: Carbetocin

Interventions

Carbetocin DRUG

carbetocin administered IV, over 1 minute following delivery of the fetal head

Also known as: Duratocin

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

Eligibility Criteria

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

You may qualify if:

• BMI ≥40kg/m2
• Elective cesarean delivery under regional anesthesia
• Gestational age ≥ 37 weeks
• No known additional risk factors for postpartum hemorrhage
• Written informed consent to participate in this study

You may not qualify if:

• Refusal to give written informed consent
• Allergy or hypersensitivity to carbetocin or oxytocin
• Conditions (other than high BMI) that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.
• Hepatic, renal, and vascular disease
• Use of general anesthesia prior to the administration of the study drug

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• Drew T, Balki M, Farine D, Ye XY, Downey K, Carvalho JCA. Carbetocin at elective caesarean section: a sequential allocation trial to determine the minimum effective dose in obese women. Anaesthesia. 2020 Mar;75(3):331-337. doi: 10.1111/anae.14944. Epub 2019 Dec 22.

  PMID: 31867715 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

• 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

Model Details: Biased coin up-and-down design.

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 14, 2018
• Study Start: November 19, 2018
• Primary Completion: May 16, 2019
• Study Completion: May 17, 2019
• Last Updated: June 7, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)