Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women (DISSUC)
The Impact of Decidual Inclusion or Sparing in a Single Unlocked Closure of a Cesarean Uterine Incision: Randomized Controlled Trial
This study compares two ways of closing the uterus during cesarean delivery. In one group, the decidual layer near the uterine cavity is included in the suture. In the other group, this layer is left out. The study will examine whether these two methods differ in how well the uterine scar heals 6 to 9 months after surgery.
Women having an elective cesarean delivery will be randomly assigned to one of the two closure methods. Scar healing will be assessed by ultrasound after delivery. The goal is to determine whether one method is associated with better cesarean scar healing and fewer scar defects.
研究概览
地位
详细说明
Cesarean scar defects, also referred to as niches or isthmoceles, are associated with gynecologic symptoms and adverse outcomes in subsequent pregnancies. The effect of uterine closure technique on scar healing remains uncertain, particularly with regard to whether the cavum-near decidual layer should be included in or excluded from the suture during cesarean closure.
This study is a prospective, randomized, controlled trial comparing two approaches to single-layer, non-locked uterine closure during elective cesarean delivery: decidual inclusion and decidual sparing. In both study groups, all operative steps are standardized except for the handling of the cavum-near decidual layer at the uterotomy margin.
Participants will be followed 6 to 9 months after cesarean delivery, including blinded ultrasound assessment of cesarean scar healing. The objective is to determine whether decidual inclusion or decidual sparing is associated with differences in postoperative uterine scar healing and cesarean scar defect formation.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Amr S. Hamza, Assoc. Prof.
- 电话号码：+41564863513
- 邮箱：amr.hamza@ksb.ch
研究联系人备份
- 姓名：Leonhard Schaeffer, Prof.
- 电话号码：+41564863506
- 邮箱：leonhard.schaeffer@ksb.ch
学习地点
-
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Canton of Aargau
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Baden、Canton of Aargau、瑞士、5400
- 招聘中
- Kantonsspital Baden
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接触：
- Amr S. Hamza, Assoc. Prof.
- 电话号码：+41564863513
- 邮箱：amr.hamza@ksb.ch
-
接触：
- Leonhard Schaeffer, Prof.
- 电话号码：+41564863506
- 邮箱：leonhard.schaeffer@ksb.ch
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Singleton, term pregnancy
- Elective cesarean section before labor onset or membrane rupture
- Maternal age >18 years
- Ability to provide informed consent
Exclusion Criteria:
- Placenta previa
- Maternal substance abuse or infection
- Suspected placenta accreta
- Diabetes
- one or more prior cesarean section
- Vulnerable participants (e.g., mental health conditions)
- Emergency cesarean sections
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Decidual Inclusion Closure
Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is included in the suture.
All other operative steps will be performed according to the standardized study protocol.
|
During the cesarean section, the uterine incision is closed with a single-layered, non-locked suture. In this technique, the decidua (the uterine lining) is included in the closure. This means that the endometrial cells are part of the suture, potentially influencing the healing process of the uterine scar. Goal: The idea is that including the decidua may promote better healing and scar formation, reducing the risk of complications such as isthmocele and improving long-term uterine health. |
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实验性的：Decidual Sparing Closure
Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is excluded from the suture.
All other operative steps will be performed according to the standardized study protocol.
|
Procedure: In this technique, the uterine incision is also closed using a single-layered non-locked suture, but the decidua is excluded from the closure. The suture is placed only through the myometrium (muscle layer) of the uterus, leaving the decidua out of the scar tissue. Goal: The intent is to observe if sparing the decidua results in better scar healing and a lower risk of isthmocele formation, as well as fewer long-term complications. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of participants with a cesarean scar niche measured by ultrasound
大体时间：6 to 9 months post-operation
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Presence of a cesarean scar niche, defined as a myometrial indentation at the cesarean scar site with a depth of at least 2 mm, assessed by postoperative ultrasound.
The outcome will be reported as the proportion of participants with a niche in each treatment group.
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6 to 9 months post-operation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Residual-to-adjacent myometrial thickness ratio
大体时间：6 to 9 months post-operation
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Ratio of residual myometrial thickness to adjacent myometrial thickness measured by ultrasound.
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6 to 9 months post-operation
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Operative time
大体时间：Periprocedural
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Operative time in minutes
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Periprocedural
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Need for additional sutures for hemostasis
大体时间：Periprocedural
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Need for additional hemostatic sutures, yes (how many: __ Number) /no
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Periprocedural
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Length of hospital stay
大体时间：Postoperative day 2
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Length of postoperative hospital stay in days
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Postoperative day 2
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Postoperative pain intensity on the 11-point Numeric Rating Scale
大体时间：Postoperative day 2
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Pain intensity assessed using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain.
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Postoperative day 2
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Postoperative bleeding
大体时间：Postoperative day 2
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Clinically relevant postoperative bleeding, yes/no
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Postoperative day 2
|
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Wound infection
大体时间：Postoperative day 2
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Postoperative wound infection, yes/no
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Postoperative day 2
|
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Postoperative fever
大体时间：Postoperative day 2
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Postoperative fever, yes/no
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Postoperative day 2
|
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Abnormal uterine bleeding
大体时间：6 to 9 months post-operation
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Abnormal uterine bleeding reported at follow-up, yes/no
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6 to 9 months post-operation
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Dysmenorrhea
大体时间：6 to 9 months post-operation
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Dysmenorrhea reported at follow-up, yes/no
|
6 to 9 months post-operation
|
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Chronic pelvic pain
大体时间：6 to 9 months post-operation
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Chronic pelvic pain reported at follow-up, yes/no
|
6 to 9 months post-operation
|
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Dyspareunia
大体时间：6 to 9 months post-operation
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Dyspareunia reported at follow-up, yes/no
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6 to 9 months post-operation
|
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Cesarean scar niche length measured by ultrasound in mm
大体时间：6 to 9 months post-operation
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Length of cesarean scar niche in mm measured by ultrasound.
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6 to 9 months post-operation
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Cesarean scar niche depth measured by ultrasound in mm
大体时间：6 to 9 months post-operation
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Depth of cesarean scar niche in mm measured by ultrasound.
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6 to 9 months post-operation
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Cesarean scar niche width measured by ultrasound in mm
大体时间：6 to 9 months post-operation
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Width of cesarean scar niche in mm measured by ultrasound.
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6 to 9 months post-operation
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Residual myometrial thickness measured by ultrasound in mm
大体时间：6 to 9 months post-operation
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Residual myometrial thickness measured by ultrasound in mm
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6 to 9 months post-operation
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Presence of intrauterine fluid on ultrasound
大体时间：6 to 9 months post-operation
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Presence or absence of intrauterine fluid on ultrasound.
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6 to 9 months post-operation
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合作者和调查者
调查人员
- 首席研究员：Amr S. Hamza, Assoc. Prof.、Kantonsspital Baden
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- StudyKSBHAM001
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IPD 计划说明
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