Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 10:56 PM
Study NCT ID:
NCT05750394
Status:
UNKNOWN
Last Update Posted:
2023-03-02
First Post:
2023-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cesarean 123 Trial: Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
Cesarean 123 Trial: Prospective Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
NOT_YET_RECRUITING
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 thickness/total 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 thickness/total 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:
True
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?: