Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285396
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-02-22
Brief Title:
Effect of Ephedrine Phenylepinephrine and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section An In-vitro Study
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
Effect of Ephedrine Phenylepinephrine and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section An In-vitro Study
Status:
RECRUITING
Status Verified Date:
2024-09
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 learn about how medication that is used to help treat low blood pressure during a Cesarean delivery CD can cause changes to the uterine muscle tissue and its ability to contract in patients with Type II and gestational diabetes
Spinal anesthesia administered during elective CD has been known to cause hypotension low blood pressure as a side effect during the procedure and is prevented by administration of vasopressors medication to raise blood pressure by the anesthesiologist after the delivery of the baby Vasopressors treat hypotension by interacting with receptors on blood vessels that increase blood pressure which can also cause changes to uterine contractility Inadequate uterine contraction after CD can expose mothers to postpartum hemorrhage PPH with diabetic patients displaying a 25-times higher risk of PPH
It is important to understand how vasopressors might affect the uterine contractility of women with Type II and gestational diabetes Since medication to contract the uterus is also routinely administered at delivery it is important to study the effect of these drugs in combination The purpose of this study is to compare uterine contractility patterns and receptor distribution in women with type II and gestational diabetic and control term pregnant patients with administration of vasopressors This will be done using small uterine tissue samples taken from the incision site following CD which will then be used for experiments in the laboratory
Spinal anesthesia administered during elective CD has been known to cause hypotension low blood pressure as a side effect during the procedure and is prevented by administration of vasopressors medication to raise blood pressure by the anesthesiologist after the delivery of the baby Vasopressors treat hypotension by interacting with receptors on blood vessels that increase blood pressure which can also cause changes to uterine contractility Inadequate uterine contraction after CD can expose mothers to postpartum hemorrhage PPH with diabetic patients displaying a 25-times higher risk of PPH
It is important to understand how vasopressors might affect the uterine contractility of women with Type II and gestational diabetes Since medication to contract the uterus is also routinely administered at delivery it is important to study the effect of these drugs in combination The purpose of this study is to compare uterine contractility patterns and receptor distribution in women with type II and gestational diabetic and control term pregnant patients with administration of vasopressors This will be done using small uterine tissue samples taken from the incision site following CD which will then be used for experiments in the laboratory
Detailed Description:
The global prevalence of diabetes has increased drastically over the past 20 years with 15 million new cases each year The prevalence of Type II diabetes in women of childbearing age has shown the greatest increase in the United States alone rising from 33 in 1990-1998 to 70 in 2020 Additionally the worldwide rate of cesarean delivery CD follows a similar trend CD procedures can be both elective and emergent with the rate of elective CD increasing by 30 in Canada since 2001 Neuraxial anesthesia administered during elective CD has been known to induce hypotension as a side effect which is then countered by administering vasopressors such as epinephrine norepinephrine and phenylephrine that act on adrenergic alpha and beta receptors on smooth muscle tissue However since these receptors are expressed on the smooth muscle layer of the uterus called the myometrium vasopressors can elicit changes in myometrial contractility Inadequate myometrial contractility during CD can expose the mother to postpartum hemorrhage PPH which is a leading cause of maternal mortality worldwide
Additionally diabetic women undergoing CD are often obese BMI 30 kgm2 or have macrosomia larger than average baby which are independent risk factors for PPH However there is still a 25-fold increased risk in PPH in Type II diabetic patients even when adjusted for diabetic-associated obesity Type II diabetics undergoing elective CD also display a reduced contractile profile as previously explored through in-vitro calcium signaling which may contribute to their increased risk of PPH Current research on myometrial contractility shows that throughout the gestational period the adrenergic receptor subtypes on the myometrial tissue may transition to more pro-contractile phenotypes which may react differently to administered vasopressors and thus affect induced contractility during CD Oxytocin a uterotonic is the standard treatment for preventing PPH administered immediately after delivery
There is currently no literature on the unique effects of vasopressors to manage hypotension in obstetric patients who are diagnosed with Type II and gestational diabetes The increased risk of PPH at CD seen in type II and Gestational diabetics mothers may be due to differences in adrenergic receptor distribution which have different affinities to the vasopressors administered No studies thus far have directly explored the role of vasopressors on myometrial contractions in this patient population
As the use of a standardized vasopressor dosage becomes more routine during elective CD it is important to understand how this will affect the myometrial contractility of women with Type II and gestational diabetes The investigators hypothesize that administration of vasopressors in full term pregnant women with type II and gestational diabetes will cause decreased myometrial contractility compared to healthy controls and that the diabetic tissue will possess a different adrenergic receptor subtype profile compared to controls
Aim 1 Investigate the differences in myometrial contractility of type II and gestational diabetic vs control term pregnant patients with administration of vasopressors
Aim 2 Determine the expression of adrenergic receptor subtypes on myometrium of term pregnant type II and gestational diabetic patients
Aim 3 Investigate the difference in downstream adrenergic pathways proteins in myometrial of type II and gestational diabetics vs control patients with administration of vasopressors
Additionally diabetic women undergoing CD are often obese BMI 30 kgm2 or have macrosomia larger than average baby which are independent risk factors for PPH However there is still a 25-fold increased risk in PPH in Type II diabetic patients even when adjusted for diabetic-associated obesity Type II diabetics undergoing elective CD also display a reduced contractile profile as previously explored through in-vitro calcium signaling which may contribute to their increased risk of PPH Current research on myometrial contractility shows that throughout the gestational period the adrenergic receptor subtypes on the myometrial tissue may transition to more pro-contractile phenotypes which may react differently to administered vasopressors and thus affect induced contractility during CD Oxytocin a uterotonic is the standard treatment for preventing PPH administered immediately after delivery
There is currently no literature on the unique effects of vasopressors to manage hypotension in obstetric patients who are diagnosed with Type II and gestational diabetes The increased risk of PPH at CD seen in type II and Gestational diabetics mothers may be due to differences in adrenergic receptor distribution which have different affinities to the vasopressors administered No studies thus far have directly explored the role of vasopressors on myometrial contractions in this patient population
As the use of a standardized vasopressor dosage becomes more routine during elective CD it is important to understand how this will affect the myometrial contractility of women with Type II and gestational diabetes The investigators hypothesize that administration of vasopressors in full term pregnant women with type II and gestational diabetes will cause decreased myometrial contractility compared to healthy controls and that the diabetic tissue will possess a different adrenergic receptor subtype profile compared to controls
Aim 1 Investigate the differences in myometrial contractility of type II and gestational diabetic vs control term pregnant patients with administration of vasopressors
Aim 2 Determine the expression of adrenergic receptor subtypes on myometrium of term pregnant type II and gestational diabetic patients
Aim 3 Investigate the difference in downstream adrenergic pathways proteins in myometrial of type II and gestational diabetics vs control patients with administration of vasopressors
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