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NCT Number: NCT02264769

Carbetocin at Elective Cesarean Delivery Part 4

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.

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms 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

The current oxytocin regimen requires the administration of a continuous infusion to achieve sustained uterotonic activity, which can be associated with a number of side effects and unpredictable efficacy. Carbetocin in a single 100 mcg dose has apparently greater efficacy, with a similar side effect profile to that of oxytocin. In addition, some studies have also shown that there is less blood loss and less requirement for additional uterotonic drugs when carbetocin is administered. Studies conducted by the investigators group at Mount Sinai have shown similar efficacy between the doses ranging from 20 to 100 mcg of carbetocin. In the investigators study, the investigators are going to compare those two doses of carbetocin to determine that 20 mcg is not inferior to 100 mcg to produce adequate uterine tone in elective cesarean delivery. This study will be a randomized, double - blind, non inferiority study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Carbetocin

Drug

Other names: Duratocin

Primary outcomes

  1. Uterine tone

    Time frame: 2 minutes

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

Secondary outcomes

  1. Uterine tone

    Time frame: 5 minutes

    Uterine tone on a scale of 0-10 at 5 minutes after completion of injection of carbetocin.

  2. Additional uterotonic medication administration

    Time frame: 24 hours

    • The use of additional uterotonic at any time post administration of carbetocin up to 24 hours post delivery.

  3. Blood loss

    Time frame: 48 hours

    Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean section.

  4. Side Effects

    Time frame: 2 hours

    Any of the following will be noted up to 2 hours post delivery: systolic blood pressure < 80% of pre-delivery values, tachycardia > 30% pre-delivery levels, bradycardia < 30% pre-delivery levels, other dysrhythmias, nausea, vomiting, chest pain, shortness of breath, headache, flushing, others

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Carbetocin at Elective Cesarean Deliveries: A Non-inferiority Study Between 20 and 100 Micrograms - Part 4

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 15, 2014
Registry last updated
May 27, 2015

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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