Ignite Creation Date:
2024-05-06 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03408054
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2018-01-17
Brief Title:
The Relaxant Effect of Nitroglycerin on Oxytocin Desensitized Human Myometrium
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
The Relaxant Effect of Nitroglycerin on Oxytocin Desensitized Human Myometrium and the Return of Contractility on Re-exposure to Oxytocin- an in Vitro Study
Status:
COMPLETED
Status Verified Date:
2019-02
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:
Oxytocin causes myometrial contraction via the oxytocin receptor OTR Desensitization of the OTR after exposure to oxytocin has been demonstrated in previous studies The resultant need for a higher oxytocin dose to cause adequate uterine contraction in vivo has also been demonstrated in laboring women having received oxytocin for labor augmentation
Achieving rapid uterine relaxation can be invaluable for maternal and fetal wellbeing in some acute obstetric emergency settings Nitroglycerin has become a commonly used agent for achieving rapid uterine relaxation amongst obstetric anesthesiologists
Previous studies have concluded that oxytocin can be used to re-establish uterine tone following nitroglycerin mediated relaxation However no studies to date have looked at the effects of nitroglycerin mediated relaxation of uterine muscle that has undergone oxytocin receptor desensitization Nor has the response to oxytocin re-exposure and return of contractility in desensitized myometrium following nitroglycerin been examined
The investigators hypothesize that nitroglycerin will reduce and inhibit uterine contractions in both oxytocin pre-treated myometrium as well as untreated myometrium in a dose dependent fashion but that myometrium that has undergone OTR desensitization will require less nitroglycerin for contractions to abate
The investigators also expect that the dose of oxytocin required to re-establish equivalent contractions will be higher in the myometrial samples which have undergone nitroglycerin mediated relaxation
Achieving rapid uterine relaxation can be invaluable for maternal and fetal wellbeing in some acute obstetric emergency settings Nitroglycerin has become a commonly used agent for achieving rapid uterine relaxation amongst obstetric anesthesiologists
Previous studies have concluded that oxytocin can be used to re-establish uterine tone following nitroglycerin mediated relaxation However no studies to date have looked at the effects of nitroglycerin mediated relaxation of uterine muscle that has undergone oxytocin receptor desensitization Nor has the response to oxytocin re-exposure and return of contractility in desensitized myometrium following nitroglycerin been examined
The investigators hypothesize that nitroglycerin will reduce and inhibit uterine contractions in both oxytocin pre-treated myometrium as well as untreated myometrium in a dose dependent fashion but that myometrium that has undergone OTR desensitization will require less nitroglycerin for contractions to abate
The investigators also expect that the dose of oxytocin required to re-establish equivalent contractions will be higher in the myometrial samples which have undergone nitroglycerin mediated relaxation
Detailed Description:
Oxytocin and nitroglycerin have opposing actions on the myometrium The pharmacological properties of quick onset and offset of action of nitroglycerin have made this the preferred drug to be used in acute scenarios where uterine relaxation is necessary
As nitroglycerin causes changes to intracellular calcium levels and the ability uterine muscle to engage in effective contraction it is plausible that the effects of nitroglycerin may interfere with subsequent uterine contractility and action of oxytocin
The situation where a difficult fetal extraction is encountered at cesarean section may be in two broad groups of patients Those pre-exposed to oxytocin and those with an oxytocin naïve myometrium Given the large observational variation in dosages of nitroglycerin usage seen in the literature we feel it is vital to investigate whether pre-exposure to oxytocin impacts on the ability of nitroglycerin to relax uterine smooth muscle Furthermore once the uterus has relaxed following nitroglycerin exposure is there a need for higher doses of oxytocin to be administered in order to re-engage the uterus in effective contraction And is this requirement further exacerbated by the phenomenon of oxytocin receptor desensitization These clinically important questions will be addressed by the design of this in vitro myometrial study
As nitroglycerin causes changes to intracellular calcium levels and the ability uterine muscle to engage in effective contraction it is plausible that the effects of nitroglycerin may interfere with subsequent uterine contractility and action of oxytocin
The situation where a difficult fetal extraction is encountered at cesarean section may be in two broad groups of patients Those pre-exposed to oxytocin and those with an oxytocin naïve myometrium Given the large observational variation in dosages of nitroglycerin usage seen in the literature we feel it is vital to investigate whether pre-exposure to oxytocin impacts on the ability of nitroglycerin to relax uterine smooth muscle Furthermore once the uterus has relaxed following nitroglycerin exposure is there a need for higher doses of oxytocin to be administered in order to re-engage the uterus in effective contraction And is this requirement further exacerbated by the phenomenon of oxytocin receptor desensitization These clinically important questions will be addressed by the design of this in vitro myometrial study
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