Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333340
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-15
Brief Title:
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding postpartum hemorrhage or PPH following cesarean delivery CD oxytocin and carbetocin Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH
This trial will focus on patients that are at increased risk of PPH with risk factors such as multiple gestation twins or more multiples large baby polyhydramnios excess amniotic fluid history of PPH body mass index greater than 40 diabetes mellitus hypertension and placenta previa
The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors
This trial will focus on patients that are at increased risk of PPH with risk factors such as multiple gestation twins or more multiples large baby polyhydramnios excess amniotic fluid history of PPH body mass index greater than 40 diabetes mellitus hypertension and placenta previa
The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors
Detailed Description:
Postpartum hemorrhage PPH is a potentially life-threatening complication and one of the leading causes of maternal mortality It has been estimated that one in every five maternal deaths occurs due to PPH globally Primary PPH is predominantly caused by uterine atony or inadequate contraction of the uterus after childbirth Active management of the third stage of labor involves prophylactic administration of a uterotonic agent before delivery of the placenta as well as delayed cord clamping and controlled traction of the umbilical cord The uterotonic administration remains the most essential component in terms of preventing PPH
Oxytocin a synthetic pituitary hormone is the most commonly used first-line uterotonic drug However because of the short half-life 3-17 min a continuous intravenous infusion is necessary to maintain uterotonic activity Carbetocin is a synthetic oxytocin analog that binds with a similar affinity to the oxytocin receptors in the myometrium Carbetocin produces stronger and more sustained action compared to oxytocin and has a longer half-life than oxytocin thus reducing the requirement for an infusion after the initial dose Recently published guidelines from the Society of Obstetrics and Gynecology SOGC have stated that Carbetocin should be considered as a first-line agent for the prevention of PPH after cesarean delivery CD The international consensus statement on the use of uterotonic agents has also recommended carbetocin as an alternative to oxytocin infusion during CD due to its longer duration of action
Trials comparing carbetocin with oxytocin in CD have shown mixed results on superiority of carbetocin over oxytocin for the need for additional uterotonics and amount of blood loss however no significant effect on blood loss 1000 ml could be found Most of the trials evaluating the prophylactic role of oxytocin and carbetocin after CD have focused on the low-risk PPH population The incidence of biological risk factors for uterine atony such as multiple gestation due to assisted reproductive techniques and obesity has progressively increased in developed countries There is still a lack of high-quality trials on the efficacy of carbetocin in high-risk parturients undergoing CD
In this study the investigators aim to compare the efficacy of carbetocin 100 mcg with oxytocin 5 IU bolus followed by continuous infusion of 250 mIUmin over 4 hours at elective CD in parturients with risk factors for uterine atony
The comparative data is still lacking for both the agents as first-line uterotonics for patients having a high risk for uterine atony undergoing cesarean delivery The result of this trial regarding the relative uterotonic efficacy and safety of the standardized prophylactic doses of both agents carbetocin and oxytocin will form the evidence base for future guidelines in high-risk parturients
Oxytocin a synthetic pituitary hormone is the most commonly used first-line uterotonic drug However because of the short half-life 3-17 min a continuous intravenous infusion is necessary to maintain uterotonic activity Carbetocin is a synthetic oxytocin analog that binds with a similar affinity to the oxytocin receptors in the myometrium Carbetocin produces stronger and more sustained action compared to oxytocin and has a longer half-life than oxytocin thus reducing the requirement for an infusion after the initial dose Recently published guidelines from the Society of Obstetrics and Gynecology SOGC have stated that Carbetocin should be considered as a first-line agent for the prevention of PPH after cesarean delivery CD The international consensus statement on the use of uterotonic agents has also recommended carbetocin as an alternative to oxytocin infusion during CD due to its longer duration of action
Trials comparing carbetocin with oxytocin in CD have shown mixed results on superiority of carbetocin over oxytocin for the need for additional uterotonics and amount of blood loss however no significant effect on blood loss 1000 ml could be found Most of the trials evaluating the prophylactic role of oxytocin and carbetocin after CD have focused on the low-risk PPH population The incidence of biological risk factors for uterine atony such as multiple gestation due to assisted reproductive techniques and obesity has progressively increased in developed countries There is still a lack of high-quality trials on the efficacy of carbetocin in high-risk parturients undergoing CD
In this study the investigators aim to compare the efficacy of carbetocin 100 mcg with oxytocin 5 IU bolus followed by continuous infusion of 250 mIUmin over 4 hours at elective CD in parturients with risk factors for uterine atony
The comparative data is still lacking for both the agents as first-line uterotonics for patients having a high risk for uterine atony undergoing cesarean delivery The result of this trial regarding the relative uterotonic efficacy and safety of the standardized prophylactic doses of both agents carbetocin and oxytocin will form the evidence base for future guidelines in high-risk parturients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None