Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01865669
Status:
COMPLETED
Last Update Posted:
2018-02-06
First Post:
2013-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity
Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Organization:
Study Overview
Official Title:
In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity
Status:
COMPLETED
Status Verified Date:
2018-02
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:
Women with advanced maternal age and morbid obesity, have a higher incidence of labor induction/ augmentation and cesarean section (CS), and are at a greater risk for postpartum hemorrhage (PPH). Oxytocin is the first line drug in the treatment of PPH, however, oxytocin receptor (OTR) desensitization has been recognized in the context of prolonged labors secondary to either endogenous or exogenous oxytocin exposure. It is unknown if oxytocin desensitization specifically affects contractility in women with advanced maternal age and morbid obesity when compared to younger or normal weight populations. Further it is not known if the higher incidence of PPH seen in these women is due to poor uterine contractility and/or poor response to oxytocin.
The investigators hypothesize that women with advanced maternal age and morbid obesity will exhibit poor myometrial contractility as compared to women that are younger and of normal body habitus, in both oxytocin pre-treated and untreated myometrium.
The investigators hypothesize that women with advanced maternal age and morbid obesity will exhibit poor myometrial contractility as compared to women that are younger and of normal body habitus, in both oxytocin pre-treated and untreated myometrium.
Detailed Description:
In view of the growing concern over the rising incidence of later maternal age and morbid obesity in the obstetric population, scientific evidence on pregnancy outcomes in these patients is timely and important. The investigators' previously validated in-vitro model provides a solid foundation for the study of myometrial contractility under controlled conditions, without any confounders that could be encountered in clinical settings. It is also likely to provide in-depth understanding of the parameters that the investigators feel are responsible for higher incidence of PPH in these patients. The investigators' study will form a basis for future modifications in oxytocin augmentation regimens and pharmacotherapy for control of PPH in these patient populations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: