Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy.

NCT04182360 | Completed

• 1 other identifier: 19-07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Poor uterine tone after the birth of a baby can cause excess bleeding (called postpartum hemorrhage or PPH). This is a major cause of maternal death worldwide. Uterotonic drugs are used to improve the muscle tone of the uterus after birth, and these are effective at reducing the incidence of PPH. 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 a study performed at Mount Sinai Hospital, the investigators have shown that smaller doses of carbetocin (14.8 mcg) are effective in achieving adequate uterine tone at elective cesarean section. In these dose-finding studies, women with multiple pregnancies have been excluded. Because women with multiple pregnancy have a higher risk of severe PPH, uterine atony, hysterectomy, prolonged hospital stay and death, it is plausible that a higher dose of carbetocin is required. This question remains unanswered. The hypothesis is that the ED90 of carbetocin in women with twin pregnancy undergoing elective cesarean delivery under regional anesthesia is greater than 20 mcg but less than 100 mcg.

Conditions

Postpartum Hemorrhage; Twin

Keywords

Pregnancy; Twins; Postpartum hemorrhage; carbetocin; uterotonic; cesarean delivery

Outcome Measures

Primary Outcomes (1)

• Uterine tone 2 minutes: questionnaire

  Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 2 minutes after completion of the carbetocin injection.

  2 minutes

Secondary Outcomes (16)

• Uterine tone 5 minutes: questionnaire

  5 minutes

• Additional uterotonics administered

  1 hour

• Estimated blood loss

  24 hours

• Intravenous fluid administered during surgery

  2 hours

• Hypotension: systolic blood pressure less than 80% of baseline

  2 hours

Study Arms (6)

Carbetocin 10mcg

ACTIVE COMPARATOR

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

Drug: Carbetocin

Carbetocin 20mcg

ACTIVE COMPARATOR

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

Drug: Carbetocin

Carbetocin 40mcg

ACTIVE COMPARATOR

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

Drug: Carbetocin

Carbetocin 60mcg

ACTIVE COMPARATOR

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

Drug: Carbetocin

Carbetocin 80mcg

ACTIVE COMPARATOR

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

Drug: Carbetocin

Carbetocin 100mcg

ACTIVE COMPARATOR

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

Drug: Carbetocin

Interventions

Carbetocin DRUG

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

You may qualify if:

• Twin Pregnancy
• Elective cesarean delivery under regional anesthesia
• Gestational age ≥ 36 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 oxytocin
• Conditions that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, severe preeclampsia (as defined by SOGC guidelines (25)), polyhydramnios, uterine fibroids, previous history of uterine atony resulting in PPH, or bleeding diathesis and obesity, defined as pre-pregnancy BMI \>40
• 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

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: November 27, 2019
• First Posted: December 2, 2019
• Study Start: October 14, 2021
• Primary Completion: April 27, 2023
• Study Completion: April 28, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)