Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05750394
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-02
First Post:
2023-02-20
Brief Title:
Cesarean 123 Trial Randomized Trial Comparing Single Double and Triple Layer Uterine Closures During Cesarean Delivery
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Cesarean 123 Trial Prospective Randomized Trial Comparing Single Double and Triple Layer Uterine Closures During Cesarean Delivery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
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:
C123T
Brief Summary:
The goal of this clinical trial is to compare post-operative uterine scar thickness in people who have had the uterus closed during cesarean sections by one of three different methods The main questions it aims to answer are
Residual myometrial thickness at the scar site assessed by MRI performed 4 months after the procedure
Myometrial niche formation assessed by MRI performed 4 months after the procedure
Scar healing ratio HR difference as defined by HR residual myometrial thicknesstotal myometrial thickness
Post-operative change in hemoglobin
Time required for hysterotomy closure
The number of extra sutures required to achieve surgeon-acceptable hemostasis
Participants undergoing scheduled cesarean sections will be randomized to one of three different uterine closure methods The methods are
1 Single layer closure using the following technique Closure of the myometrium and serosa with one barbed suture using a running unlocked technique The endometrium should be excluded
2 Double layer closure using the following technique Closure of the full thickness of the myometrium with one smooth suture using a running locked technique The endometrium should be excluded Followed by imbrication of the second layer with one smooth suture using a running unlocked technique
3 Triple layer closure of Endometrium Myometrium and Serosa EMS using one of the the following two techniques Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture using a running unlocked technique followed by closure of the remaining myometrium and serosa with one barbed suture using a running unlocked technique Or Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture on using a running unlocked technique followed by closure of the remaining myometrium with one barbed suture a running unlocked technique followed by closure of the serosa with one barbed suture using a running unlocked technique
Four months after the surgery participants will have a MRI of the pelvis to assess the scar on the uterus
Residual myometrial thickness at the scar site assessed by MRI performed 4 months after the procedure
Myometrial niche formation assessed by MRI performed 4 months after the procedure
Scar healing ratio HR difference as defined by HR residual myometrial thicknesstotal myometrial thickness
Post-operative change in hemoglobin
Time required for hysterotomy closure
The number of extra sutures required to achieve surgeon-acceptable hemostasis
Participants undergoing scheduled cesarean sections will be randomized to one of three different uterine closure methods The methods are
1 Single layer closure using the following technique Closure of the myometrium and serosa with one barbed suture using a running unlocked technique The endometrium should be excluded
2 Double layer closure using the following technique Closure of the full thickness of the myometrium with one smooth suture using a running locked technique The endometrium should be excluded Followed by imbrication of the second layer with one smooth suture using a running unlocked technique
3 Triple layer closure of Endometrium Myometrium and Serosa EMS using one of the the following two techniques Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture using a running unlocked technique followed by closure of the remaining myometrium and serosa with one barbed suture using a running unlocked technique Or Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture on using a running unlocked technique followed by closure of the remaining myometrium with one barbed suture a running unlocked technique followed by closure of the serosa with one barbed suture using a running unlocked technique
Four months after the surgery participants will have a MRI of the pelvis to assess the scar on the uterus
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None