Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04766073
Status:
RECRUITING
Last Update Posted:
2023-09-25
First Post:
2021-02-17
Brief Title:
Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-09
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:
In the last decade we have been exposed to the complication of a caesarean section called a niche A niche is an anaerobic defect in the location of the cesarean section which represents the discontinuity of the endometrium and myometrium A niche is usually diagnosed by ultrasound and can also be diagnosed by hysterosalpingogram or hysteroscopy In the presence of a niche women suffer more frequently from irregular bleeding dysmenorrhea chronic pelvic pain and dyspareunia We believe that a combination of tissue ischemia and thinning of the scar tissue that forms causes a niche to form Large randomized studies regarding the preferred surgical technique in cesarean section including various methods of incision closure have found that there is no single method that is obviously superior However these studies did not examine niche formation as a complication of cesarean section
In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation
In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation
Detailed Description:
None
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