Cesarean 123 Trial: Prospective Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Myometrial thickness
研究概览
简要总结
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:
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Radiologist blinded to closure method
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Singleton gestation
- •Nonurgent primary or secondary cesarean delivery at greater than 35w6d
- •Body Mass Index (BMI) <35 kg/m^2
排除标准
- •More than 1 prior cesarean delivery
- •Multiple gestation
- •Known coagulation disorder or current use of anti-coagulants
- •Mullerian anomalies
- •Placenta previa
研究组 & 干预措施
Single Layer Closure
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.
干预措施: Uterine layers closed (Procedure)
Single Layer Closure
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.
干预措施: Suture Type (Device)
Single Layer Closure
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.
干预措施: Endometrium (Procedure)
Double Layer Closure
Double layer closure using the following technique:
- 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.
- Imbrication of the first layer with one (1) Monocryl suture on a CT needle using a running un-locked technique
干预措施: Uterine layers closed (Procedure)
Double Layer Closure
Double layer closure using the following technique:
- 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.
- Imbrication of the first layer with one (1) Monocryl suture on a CT needle using a running un-locked technique
干预措施: Suture Type (Device)
Double Layer Closure
Double layer closure using the following technique:
- 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.
- Imbrication of the first layer with one (1) Monocryl suture on a CT needle using a running un-locked technique
干预措施: Endometrium (Procedure)
Triple Layer Closure
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 (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique
- 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
- 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
- Closure of the remaining myometrium with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique
- Closure of the serosa with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique
干预措施: Uterine layers closed (Procedure)
Triple Layer Closure
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 (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique
- 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
- 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
- Closure of the remaining myometrium with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique
- Closure of the serosa with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique
干预措施: Suture Type (Device)
Triple Layer Closure
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 (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique
- 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
- 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
- Closure of the remaining myometrium with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique
- Closure of the serosa with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique
干预措施: Endometrium (Procedure)
结局指标
主要结局
Myometrial thickness
时间窗: 4 months
Residual myometrial thickness at the scar site assessed by MRI performed
次要结局
- Niche(4 months)
- Scar ratio(4 month)
- Blood loss(1 day)
- Extra sutures(Immediate)
- Time for closure(Immediate)
研究者
James Greenberg, MD
Vice Chair OB/GYN
Brigham and Women's Hospital