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Completed

NCT Number: NCT04902729

Oxytocin vs Carbetocin at Cesarean Delivery in Women With Morbid Obesity

Postpartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug for the active management of third stage labor, to reduce the risk of PPH and help deliver the placenta. Carbetocin is currently recommended by the SOGC (Society of Obstetricans & Gynecologists of Canada), and is a relatively newer drug with a longer duration of action. It has been previously demonstrated that women with elevated BMI require higher doses of these drugs to induce adequate uterine contraction and dose finding studies undertaken at Mount Sinai Hospital have shown that the ED 90 in obese patients to be carbetocin 80 mcg and oxytocin 1IU. Furthermore, previous studies have indicated that the use of carbetocin over oxytocin in non-obese popultion is associated with reduced bleeding and requirement of additional uterotonic medications. No study has directly compared the two drugs in obese parturients in a head to head clinical trial; therefore a double-blind randomized controlled trial is necessary to show the non-inferiority of carbetocin against the current standard of care at Mount Sinai hospital, which is oxytocin.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

About this study

Obesity in pregnancy is defined as a Body Mass Index (BMI) above 30 kg/m2 and is often cited as a risk factor for PPH after cesarean delivery.

The World Health organization (WHO) recommends that uterotonic medications are routinely administered at cesarean delivery for the active management of the third stage of labor, both to facilitate delivery of the placenta and to reduce the risk of PPH. The optimal regimen for active management of third stage of labor is yet to be fully determined and obesity adds another layer of complexity and risk, with higher doses required to induce adequate uterine contraction. While oxytocin is the most commonly used drug world-wide, multiple agents are available and there is no clear consensus as to which drug should be first choice. Multiple studies have shown that carbetocin is associated with reduced post-partum bleeding, need for blood transfusion and additional uterotonic medications, in the non-obese population.

The results of this study will provide evidence on the non-inferiority of carbetocin when compared directly to the current standard of care at Mount Sinai hospital, which is oxytocin.

The investigators hypothesize that when administered in equipotent doses, carbetocin would be non-inferior to oxytocin in women with BMI ≥40 kg/m2 undergoing elective cesarean delivery.

The investigators hope to prove that the difference between uterine tone elicited by carbetocin falls within the inferiority margin of -1.2 using a verbal numerical rating score.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI≥40 kg/m2
  • Elective cesarean delivery under spinal, epidural, or combined spinal-epidural anaesthesia
  • Written informed consent
  • Full term pregnancy (37+0 to 40+6 weeks gestation)
  • Non-labouring patients

Exclusion criteria

  • Refusal to give written informed consent
  • Allergy or hypersensitivity to carbetocin or oxytocin
  • Laboring patients
  • Need for general anaesthesia
  • Conditions that predispose to uterine atony and postpartum haemorrhage including but not limited to:
  • Placenta previa
  • Multiple gestations
  • Preeclampsia
  • Eclampsia
  • Polyhydramnios
  • Uterine fibroids
  • Previous history of uterine atony and postpartum bleeding
  • Bleeding diathesis
  • Hepatic, renal, and cardiovascular disease

Treatment and study plan

Carbetocin

Drug

Patient is given carbetocin (80mcg) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.

Other names: Duratocin

Oxytocin

Drug

Patient is given oxytocin (1IU) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby, followed by infusion 80 mU/min (40 IU in 1L given at a rate of 120 mL/h).

Other names: Pitocin

Primary outcomes

  1. Uterine Tone 3 minutes

    Time frame: 3 minutes

    The primary outcome will be the intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 3 minutes, from the completion of delivery of the drug, utilising a VNRS scale of 0-10.

Secondary outcomes

  1. Uterine Tone 5 minutes

    Time frame: 5 min

    Intensity of uterine tone on a VNRS scale of 0-10 as evaluated by the obstetrician at 5 minutes after completion of injection of the bolus study drug.

  2. Uterine Tone 10 minutes

    Time frame: 10 min

    Intensity of uterine tone on a VNRS scale of 0-10 as evaluated by the obstetrician at 10 minutes after completion of injection of the bolus study drug.

  3. Additional uterotonics - operating room

    Time frame: 1-2 hours, length of surgery will vary

    The use of additional uterotonic agents in the operating room

  4. Additional uterotonics - Post Anesthesia Care Unit (PACU)

    Time frame: 4 hours

    The use of additional uterotonic agents at any time after admission to the recovery area (Post Anesthesia Care Unit (PACU)) until transfer to the post partum ward.

  5. Additional uterotonics - 24 hours

    Time frame: 24 hours

    The use of additional uterotonic agents at any time after discharge from the recovery area (Post Anesthesia Care Unit (PACU)) and up to 24 hours post delivery

  6. Estimated blood loss calculated

    Time frame: 24 hours

    Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 24 hours after the cesarean section.

  7. Estimated blood loss, visual estimate provided by the obstetrician

    Time frame: 2 hours

    Blood loss in ml, as reported by the obstetrician at the end of the surgery.

  8. Hypotension: systolic blood pressure less than 80% of baseline

    Time frame: 2 hours

    Systolic blood pressure < 80% of baseline, from drug administration until end of surgery

  9. Hypertension: systolic blood pressure greater than 120% of baseline

    Time frame: 2 hours

    Systolic blood pressure > 120% of baseline, from drug administration until end of surgery

  10. Tachycardia: heart rate greater than 130% of baseline

    Time frame: 2 hours

    Heart rate > 130% of baseline, from drug administration until end of surgery

  11. Bradycardia: heart rate less than 70% of baseline

    Time frame: 2 hours

    Heart rate < 70% of baseline, from drug administration until end of surgery

  12. Presence of ventricular tachycardia: ECG

    Time frame: 2 hours

    Presence of ventricular tachycardia as recorded by ECG, from drug administration until end of surgery

  13. Presence of atrial fibrillation: ECG

    Time frame: 2 hours

    Presence of atrial fibrillation as recorded by ECG, from drug administration until end of surgery

  14. Presence of atrial flutter: ECG

    Time frame: 2 hours

    Presence of atrial flutter as recorded by ECG, from drug administration until end of surgery

  15. Presence of nausea: questionnaire

    Time frame: 2 hours

    The presence of nausea and number of episodes, from drug administration until end of surgery, as reported by the patient

  16. Presence of vomiting: questionnaire

    Time frame: 2 hours

    The presence of vomiting and number of episodes, from drug administration until end of surgery

  17. Presence of chest pain: questionnaire

    Time frame: 2 hours

    Any presence of chest pain, from drug administration until end of surgery, as reported by the patient

  18. Presence of shortness of breath: questionnaire

    Time frame: 2 hours

    Any presence of shortness of breath, from drug administration until end of surgery, as reported by the patient

  19. Presence of headache: questionnaire

    Time frame: 2 hours

    Any presence of headache, from drug administration until end of surgery, as reported by the patient

  20. Presence of flushing: questionnaire

    Time frame: 2 hours

    Any presence of flushing, from drug administration until end of surgery

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Oxytocin Vs Carbetocin at Cesarean Delivery in Women With Morbid Obesity: Double-blind, Randomised Control, Non-inferiority Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 26, 2021
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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