Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285409
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-02-22
Brief Title:
Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This study will investigate the effects of drugs called uterotonics that help with the contraction of the uterus after a baby is born This uterine contraction is very important to stop the bleeding after delivery An uncontracted uterine state is called uterine atony which can lead to an excessive amount of post-delivery bleeding Carbetocin is an uterotonic drug that works well to prevent post-delivery bleeding In some cases carbetocin is not enough to contract the uterus and ongoing bleeding continues When that happens there are other uterotonic medications that can be used In this study we aim to find which uterotonic drug amongst those available oxytocin carbetocin ergometrine or carboprost is more effective to lower the risk of post-delivery bleeding once carbetocin has already been administered
This study will be done by using a very small sample of uterine tissue taken from the incision site following delivery by cesarean section The sample is taken to the laboratory and will be exposed to carbetocin followed by other uterotonic drugs The information obtained from this study will help modify the treatment for uterine atony and post-delivery bleeding to lower the risk further
This study will be done by using a very small sample of uterine tissue taken from the incision site following delivery by cesarean section The sample is taken to the laboratory and will be exposed to carbetocin followed by other uterotonic drugs The information obtained from this study will help modify the treatment for uterine atony and post-delivery bleeding to lower the risk further
Detailed Description:
Postpartum hemorrhage PPH remains to be one of the leading causes of maternal morbidity and mortality It has been noted that an increasing number of PPH is attributed to the increased incidence of uterine atony Carbetocin is the first line therapy for prevention and treatment of uterine atony Carbetocin is currently used as a single dose treatment without an option of redosing It has been proven that exposure to oxytocin during labour results in a decrease in myometrial contractions previous studies shows that the current dose of carbetocin 100 µcg is insufficient for optimal uterine contraction in failure to progress caesarean section
According to current guidelines for medical management of PPH the first line therapy for post CD uterotonic agent in Canada is carbetocin It is a reliable and safe agent however it is a one shot option for treatment due to its longer half-life 40 minutes The clinicians are reluctant to re-dose carbetocin after an initial failure to achieve adequate uterine tone with the assumption that the oxytocin receptors would likely be saturated with the agonist It is unknown whether re-dosing with oxytocics carbetocin or oxytocin would help augment myometrial contractions thereby lowering post-partum bleeding and improving patient outcomes It is also unknown if prior carbetocin administration would affect myometrial contractility induced by other second line uterotonics such as ergometrine or carboprost
This study is essential to answer the clinical question of the efficacy of re-dosing with either oxytocics or second line agents uterotonics following the first prophylactic dose of carbetocin in women with previously desensitized myometrium This will help us better understand the comparative myometrial contractility response for a range of uterotonics
The primary hypothesis of this study is that treating a second dose of oxytocicscarbetocinoxytocin in oxytocin pre-treated myometrium after the first standard bolus of 100 µcg carbetocin will cause enhanced myometrial contraction compared to control
The second hypothesis is that the efficacy of second line agents ergometrine or carboprost would not be as effective ie they are likely to be less effective than oxytocics
According to current guidelines for medical management of PPH the first line therapy for post CD uterotonic agent in Canada is carbetocin It is a reliable and safe agent however it is a one shot option for treatment due to its longer half-life 40 minutes The clinicians are reluctant to re-dose carbetocin after an initial failure to achieve adequate uterine tone with the assumption that the oxytocin receptors would likely be saturated with the agonist It is unknown whether re-dosing with oxytocics carbetocin or oxytocin would help augment myometrial contractions thereby lowering post-partum bleeding and improving patient outcomes It is also unknown if prior carbetocin administration would affect myometrial contractility induced by other second line uterotonics such as ergometrine or carboprost
This study is essential to answer the clinical question of the efficacy of re-dosing with either oxytocics or second line agents uterotonics following the first prophylactic dose of carbetocin in women with previously desensitized myometrium This will help us better understand the comparative myometrial contractility response for a range of uterotonics
The primary hypothesis of this study is that treating a second dose of oxytocicscarbetocinoxytocin in oxytocin pre-treated myometrium after the first standard bolus of 100 µcg carbetocin will cause enhanced myometrial contraction compared to control
The second hypothesis is that the efficacy of second line agents ergometrine or carboprost would not be as effective ie they are likely to be less effective than oxytocics
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