High Segmental Hysterotomy vs. Low Segmental Hysterotomy: Association With the Incidence of Uterine Wall Defects After Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Incidence of uterine wall defect at the scar site
研究概览
简要总结
The purpose of this clinical trial is to compare the incidence of defects in the uterine wall at the site of the scar (niche) and surgical complications when using high-segment versus low-segment hysterotomy, with both cross-suturing and non-cross-suturing techniques, in pregnant patients undergoing their first cesarean section.
Researchers will compare four arms:
- Low Segment Hysterotomy + Crossed hysterorrhaphy
- High Segment Hysterotomy + Crossed hysterorrhaphy
- Low Segment Hysterotomy + Non-Crossed hysterorrhaphy
- High Segment Hysterotomy + Non-Crossed hysterorrhaphy
Participants will:
- Cesarean delivery
- Attend a follow up appointment between 6 to 16 weeks post surgery where will be perform a transvaginal sonography.
详细描述
This study will be conducted as a single-blind trial. Patients will be approached in the delivery room, where a comprehensive review of the inclusion and exclusion criteria checklist will be conducted to determine their eligibility for the study. Once eligible patients are identified, the study will be thoroughly explained to them, highlighting its purpose, potential benefits, and risks. This will be followed by a detailed discussion of the informed consent form to ensure that participants fully understand what their involvement entails.
Upon obtaining informed consent, a randomization process will be implemented to allocate participants to one of the four study arms. The assigned procedure will be performed by their attending gynecologist, who is familiar with their medical history and care needs. Throughout the study, various outcomes will be measured, including intraoperative findings, postoperative recovery, and post-discharge progress.
A transvaginal pelvic ultrasound will be ordered to be performed between 6 and 16 weeks postoperatively. During the single follow-up appointment, this imaging evaluation will be carried out to determine the presence or absence of an isthmocele, as well as to assess its characteristics, such as size and location, if present.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women aged ≥ 18 years.
- •Confirmed pregnancy through clinical history or ultrasound between 36 and 42 weeks of gestation.
- •Indication by the attending gynecologist for a first cesarean section, either emergent or elective.
排除标准
- •History of myometrial intervention, such as myomectomy.
- •History of genetic or acquired conditions that alter the anatomy of the uterus.
- •History of coagulation disorders.
- •History of connective tissue disorders, such as Lupus and Scleroderma, which may affect healing.
- •Hemodynamically unstable patients due to a clinical condition prior to performing the cesarean section.
- •Failure to sign the informed consent.
研究组 & 干预措施
Low Segment Hysterotomy + Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of Low Segment Hysterotomy and Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
干预措施: Low segment hysterotomy (Procedure)
Low Segment Hysterotomy + Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of Low Segment Hysterotomy and Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
干预措施: Crossed hysterorrhaphy (Procedure)
High Segment Hysterotomy + Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of High Segment Hysterotomy and Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
干预措施: High segment hysterotomy (Procedure)
High Segment Hysterotomy + Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of High Segment Hysterotomy and Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
干预措施: Crossed hysterorrhaphy (Procedure)
Low Segment Hysterotomy + Non-Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of Low Segment Hysterotomy and Non-Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
干预措施: Low segment hysterotomy (Procedure)
Low Segment Hysterotomy + Non-Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of Low Segment Hysterotomy and Non-Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
干预措施: Non-Crossed hysterorrhaphy (Procedure)
High Segment Hysterotomy + Non-Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of High Segment Hysterotomy and Non-Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
干预措施: High segment hysterotomy (Procedure)
High Segment Hysterotomy + Non-Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of High Segment Hysterotomy and Non-Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
干预措施: Non-Crossed hysterorrhaphy (Procedure)
结局指标
主要结局
Incidence of uterine wall defect at the scar site
时间窗: 6 to 16 weeks post-hysterotomy
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
次要结局
- Residual myometrial thickness of the uterine wall defect at the scar site(6 to 16 weeks post-hysterotomy)
- Myometrial thickness in the portion immediately cephalad to the residual myometrial defect(6 to 16 weeks post-hysterotomy)
- Myometrial thickness in the portion immediately caudal to the residual myometrial defect(6 to 16 weeks post-hysterotomy)
- Size of the uterine wall defect(6 to 16 weeks post-hysterotomy)
- Depth of the defect in the uterine wall(6 to 16 weeks post-hysterotomy)