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NCT Number: NCT04182360

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

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.

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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 Twin Urogenital Diseases Uterine Hemorrhage

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

About this study

There is a lack of consensus as to what the optimal uterotonic regime is globally. Furthermore, variability in the international guidelines regarding the choice of first line uterotonic in prevention of PPH adds to the confusion. With the widespread availability of carbetocin in some developed countries, including Canada, the question of which uterotonic to adopt and at which dose becomes even more difficult to ascertain. Studies that have currently been published suggest the ED90 doses of carbetocin and oxytocin provide adequate uterine contraction with possibly fewer side effects associated with the lower dose regimens. There is evidence to suggest that lower doses of both carbetocin provide equivalent uterine contractions with a better side effect profile in patients with a singleton pregnancy. However, there is no clinical dosing data specifically for patients with twin pregnancy. The results of our study will provide guidance to obstetric and anesthetic providers worldwide when deciding what dose of carbetocin to use in women with twin pregnancy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Carbetocin

Drug

Carbetocin administered intravenously, over 1 minute following delivery of the fetal head.

Other names: Duratocin

Primary outcomes

  1. Uterine tone 2 minutes: questionnaire

    Time frame: 2 minutes

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

Secondary outcomes

  1. Uterine tone 5 minutes: questionnaire

    Time frame: 5 minutes

    Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 5 minutes after completion of the carbetocin injection.

  2. Additional uterotonics administered

    Time frame: 1 hour

    The drug, dosage and timing of any additional uterotonic medication given during surgery.

  3. Estimated blood loss

    Time frame: 24 hours

    Blood loss will be calculated through the difference in hematocrit values assessed prior to surgery and 24 hours after the cesarean delivery.

  4. Intravenous fluid administered during surgery

    Time frame: 2 hours

    The total volume (ml) of fluid administered from entering the operating room to skin closure.

  5. 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

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

    Time frame: 2 hours

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

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

    Time frame: 2 hours

    Heart rate < 70% of baseline or a heart rate < 50bpm, from drug administration until end of surgery

  8. Presence of ventricular tachycardia: ECG

    Time frame: 2 hours

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

  9. Presence of atrial fibrillation: ECG

    Time frame: 2 hours

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

  10. Presence of atrial flutter: ECG

    Time frame: 2 hours

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

  11. 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

  12. Presence of vomiting: questionnaire

    Time frame: 2 hours

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

  13. 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

  14. 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

  15. Presence of headache: questionnaire

    Time frame: 2 hours

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

  16. 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2019
Registry last updated
Jul 6, 2023

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

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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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