Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Must be taking: Oxytocin
Disqualifiers: Hypertension, Cardiac disease, others
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This study is designed to determine the minimal effective oxytocin maintenance infusion required in labouring women undergoing cesarean delivery to achieve the best effect. Oxytocin is a drug that is routinely used to help the uterus to contract and keep it contracted after delivery. Consequently, it will help to reduce blood loss after delivery. In order to determine the minimal effective dose, the investigators will conduct a dose-finding study. The first patient will receive a set oxytocin infusion. The next patient's infusion dose of oxytocin, will either increase or decrease, depending on how the previous patient responds in terms of uterine tone. If the response is satisfactory with the infusion dose used, the next patient will either receive the same infusion dose or it will be decreased depending on a probability of 1:9. If the response is not satisfactory, then the infusion dose will increase for the next patient. The dose for each patient will be determined based on the results of the uterine contraction of the previous patient.
The investigators hypothesize that the ED90 of the oxytocin infusion rate to maintain adequate uterine tone in labouring women with induced or augmented labour undergoing cesarean delivery, following an initial effective bolus dose, would be lower than 0.74 IU/min (44 IU/h), which was found as the ED90 in a previous study, without an initial bolus dose prior to the infusion.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug oxytocin for postpartum hemorrhage?
Oxytocin is widely used as the standard treatment to prevent postpartum hemorrhage, which is a leading cause of maternal death. It is routinely administered after childbirth to help the uterus contract and reduce bleeding.
12345Is oxytocin safe for use in humans?
Oxytocin, including its synthetic form Syntocinon, has been used safely in thousands of patients without observed side effects like vasospasm (narrowing of blood vessels) or anaphylactic reaction (severe allergic reaction). It is generally considered safe when used with proper supervision and dosage adjustment.
23678How is the drug oxytocin unique in treating postpartum hemorrhage?
Oxytocin is unique because it is the most commonly used drug to prevent postpartum hemorrhage, and it can be administered both intravenously (through a vein) and intramuscularly (into a muscle), making it versatile for different settings, including emergencies and low-resource areas.
59101112Eligibility Criteria
This trial is for women in labor who are having a cesarean delivery under neuraxial anesthesia and have been exposed to oxytocin for at least 3 hours. It's not suitable for those with hypertension, severe heart issues, allergies to oxytocin, contraindications to neuraxial anesthesia, or if general anesthesia becomes necessary during surgery.Inclusion Criteria
I had labor induced or augmented and will have a cesarean with spinal or epidural anesthesia after at least 3 hours of oxytocin.
Exclusion Criteria
I refuse to sign the consent form for this trial.
All patients who declare allergy or hypersensitivity to oxytocin
I have a history of high blood pressure or serious heart conditions.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive varying doses of oxytocin infusion to determine the minimal effective dose for maintaining uterine tone during cesarean delivery
2 hours
Intraoperative monitoring
Postoperative Monitoring
Participants are monitored for uterine tone and other physiological responses in the post anesthetic care unit (PACU)
2 hours
Continuous monitoring in PACU
Follow-up
Participants are monitored for safety and effectiveness after treatment, including blood loss and need for additional uterotonic medication
24 hours
Participant Groups
The study aims to find the lowest effective dose of oxytocin infusion needed after an initial bolus dose during cesarean delivery. The dosage will be adjusted up or down based on the previous patient's uterine response, aiming for better control of blood loss post-delivery.
17Treatment groups
Experimental Treatment
Group I: Oxytocin infusion rate 8 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 8 IU/h.
Group II: Oxytocin infusion rate 6 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 6 IU/h.
Group III: Oxytocin infusion rate 4 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 4 IU/h.
Group IV: Oxytocin infusion rate 36 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 36 IU/h.
Group V: Oxytocin infusion rate 34 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 34 IU/h.
Group VI: Oxytocin infusion rate 32 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 32 IU/h.
Group VII: Oxytocin infusion rate 30 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 30 IU/h.
Group VIII: Oxytocin infusion rate 28 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 28 IU/h.
Group IX: Oxytocin infusion rate 26 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 26 IU/h.
Group X: Oxytocin infusion rate 24 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 24 IU/h.
Group XI: Oxytocin infusion rate 22 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 22 IU/h.
Group XII: Oxytocin infusion rate 20 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 20 IU/h.
Group XIII: Oxytocin infusion rate 18 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 18 IU/h.
Group XIV: Oxytocin infusion rate 16 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 16 IU/h.
Group XV: Oxytocin infusion rate 14 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 14 IU/h.
Group XVI: Oxytocin infusion rate 12 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 12 IU/h.
Group XVII: Oxytocin infusion rate 10 IU/hExperimental Treatment1 Intervention
The maintenance infusion rate of oxytocin will be 10 IU/h.
Oxytocin is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Pitocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇪🇺 Approved in European Union as Syntocinon for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇨🇦 Approved in Canada as Oxytocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇦🇺 Approved in Australia as Oxytocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mount Sinai HospitalToronto, Canada
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Who Is Running the Clinical Trial?
Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
References
Hemodynamic effects of carbetocin administered as an intravenous bolus or infusion during cesarean delivery. [2022]Postpartum hemorrhage is the leading cause of maternal mortality. Oxytocin being the most popular uterotonic agent, has been routinely administered after both vaginal delivery and cesarean section. Carbetocin is a newer uterotonic agent and provides the benefit of a longer duration of action without additional administration post-delivery.
Carbetocin versus oxytocin for prevention of postpartum hemorrhage in hypertensive women undergoing elective cesarean section. [2021]Assess the efficacy and safety of carbetocin, versus oxytocin in the prevention of postpartum hemorrhage in hypertensive women.
Effectiveness and safety of carboxytocin versus oxytocin in preventing postpartum hemorrhage: A systematic review and meta-analysis. [2022]This study compared the effectiveness and safety of carbetocin and oxytocin in preventing postpartum hemorrhage (PPH).
Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth. [2022]Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin.
[The Role of Oxytocin in the Prevention of Postpartum Hemorrhage in Low-Resource Settings]. [2022]Postpartum hemorrhage remains one of the leading causes of maternal death globally. Oxytocin is the uterotonic agent of choice for the prophylaxis of this complication. However, its use in low-resource settings is associated with clinical, political, economic and cultural constraints. The goal of this article is to describe the use of oxytocin for postpartum hemorrhage prophylaxis in low-resource settings.
Synthetic oxytocin. [2018]A synthetic oxytocin, Syntocinon(R), was used in 3,342 obstetrical patients for a wide variety of indications. It was concluded that the preparation is as effective as natural oxytocin.(1) There were no side effects observed, particularly vasospasm or anaphylactic reaction. Its use in clinical obstetrics can be recommended provided there is a proper indication for its use and the need for close supervision and individual adjustment of dosage is recognized.
A randomised trial of carbetocin versus syntometrine in the management of the third stage of labour. [2021]Syntometrine is an effective uterotonic agent used in preventing primary postpartum haemorrhage but has adverse effects including nausea, vomiting, hypertension and coronary artery spasm. Carbetocin is a newly developed long-acting oxytocin analogue that might be used as an uterotonic agent. We compare the efficacy and safety of intramuscular (IM) carbetocin with IM syntometrine in preventing primary postpartum haemorrhage.
Carbetocin for the prevention of postpartum hemorrhage: a systematic review. [2018]The objective of this review was to evaluate the efficacy and safety of carbetocin in the prevention of postpartum hemorrhage. All trials found during a targeted Medline and Cochrane database search were screened for eligibility. Outcome measures were estimated blood loss, uterine tone, amount and type of lochia, fundal position after delivery (number of centimeters above or below the umbilicus), side-effects, adverse effects, vital signs, levels of hemoglobin/hematocrit before delivery compared with 24 or 48 hours postpartum, the need for additional uterotonic therapy, and/or uterine massage and duration of the third stage of labor. The retrieved studies were difficult to compare because of differences in study design and outcome. We conclude that carbetocin probably is as effective as oxytocin or syntometrine in the prophylactic management of the third stage of labor. Also carbetocin has a similar safety profile to oxytocin, which is now used as a standard prophylactic treatment. However, more research on this subject is needed.
A survey of physicians' attitudes toward uterotonic administration in parturients undergoing cesarean section. [2019]Oxytocin is globally accepted as first-line treatment for prevention of post-partum hemorrhage. However, there is wide variability in its use in clinical practice. In this study, we aimed to evaluate obstetricians and anesthesiologists attitudes towards uterotonic practices in Israel.
The risk of postpartum hemorrhage when lowering the oxytocin dose in planned cesarean section, a pilot study. [2021]Oxytocin is the drug of choice in preventing postpartum hemorrhage (PPH). The aim was to compare the peroperative- and total blood loss within two hours and PPH after planned cesarean section (CS) when receiving 2.5 IU vs 5.0 IU of oxytocin in different risk groups for PPH.
Role of oxytocin in prevention of postpartum hemorrhage in unplanned out-of-hospital deliveries treated by emergency medical services. [2020]Intramuscular or intravenous oxytocin is used in out-of-hospital emergency care in Finland to prevent postpartum hemorrhage after unplanned out-of-hospital deliveries. However, the use of oxytocin by emergency medical services is based on in-hospital studies. The aim of this study was to determine whether the use of oxytocin is associated with diminished postpartum hemorrhage after unplanned out-of-hospital deliveries.
Dose and duration of oxytocin to prevent postpartum hemorrhage: a review. [2022]Oxytocin, the most commonly used uterotonic agent in the United States to prevent postpartum hemorrhage, has no established standard dose. The aim of this review is to present data on oxytocin dosing for the prevention of postpartum hemorrhage.