Cesarean 123 Trial: Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery
- Conditions
- Pregnancy Related
- Interventions
- Procedure: Uterine layers closedDevice: Suture TypeProcedure: Endometrium
- Registration Number
- NCT05750394
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 120
- 18 years or older
- Singleton gestation
- Nonurgent primary or secondary cesarean delivery at greater than 35w6d
- Body Mass Index (BMI) <35 kg/m^2
- More than 1 prior cesarean delivery
- Multiple gestation
- Known coagulation disorder or current use of anti-coagulants
- Mullerian anomalies
- Placenta previa
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single Layer Closure Uterine layers closed Single layer closure using the following technique: a. Closure of the myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique. The endometrium should be excluded. Single Layer Closure Endometrium Single layer closure using the following technique: a. Closure of the myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique. The endometrium should be excluded. Triple Layer Closure Suture Type Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: 1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique 2. Closure of the remaining myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique or 1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique 2. Closure of the remaining myometrium with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique 3. Closure of the serosa with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique Triple Layer Closure Endometrium Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: 1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique 2. Closure of the remaining myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique or 1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique 2. Closure of the remaining myometrium with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique 3. Closure of the serosa with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique Single Layer Closure Suture Type Single layer closure using the following technique: a. Closure of the myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique. The endometrium should be excluded. Double Layer Closure Uterine layers closed Double layer closure using the following technique: 1. Closure of the full thickness of the myometrium with one (1) Monocryl suture on a CT needle using a running locked technique. The endometrium should be excluded. 2. Imbrication of the first layer with one (1) Monocryl suture on a CT needle using a running un-locked technique Double Layer Closure Endometrium Double layer closure using the following technique: 1. Closure of the full thickness of the myometrium with one (1) Monocryl suture on a CT needle using a running locked technique. The endometrium should be excluded. 2. Imbrication of the first layer with one (1) Monocryl suture on a CT needle using a running un-locked technique Triple Layer Closure Uterine layers closed Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: 1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique 2. Closure of the remaining myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique or 1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique 2. Closure of the remaining myometrium with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique 3. Closure of the serosa with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique Double Layer Closure Suture Type Double layer closure using the following technique: 1. Closure of the full thickness of the myometrium with one (1) Monocryl suture on a CT needle using a running locked technique. The endometrium should be excluded. 2. Imbrication of the first layer with one (1) Monocryl suture on a CT needle using a running un-locked technique
- Primary Outcome Measures
Name Time Method Myometrial thickness 4 months Residual myometrial thickness at the scar site assessed by MRI performed
- Secondary Outcome Measures
Name Time Method Niche 4 months Myometrial niche formation assessed by MRI performed
Scar ratio 4 month Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness by MRI
Blood loss 1 day Post-operative change in hemoglobin
Extra sutures Immediate The number of extra sutures required to achieve surgeon-acceptable hemostasis
Time for closure Immediate Time required for hysterotomy closure