Incision-Parallel Double-Layer Non-Locking Versus Single-Layer Locked Uterine Closure After Primary Caesarean Delivery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of Cesarean Scar Defect
研究概览
简要总结
This randomized controlled trial was conducted to compare two uterine closure techniques in women undergoing primary cesarean delivery. The study evaluated whether the technique used to close the uterine incision affects the development and characteristics of cesarean scar defects (CSD).
Participants were randomly assigned in a 1:1 ratio to either a conventional single-layer locked continuous uterine closure technique or a double-layer, incision-parallel, nonlocking continuous closure technique. Cesarean scar healing was evaluated at least three months after delivery using transvaginal ultrasonography. The primary outcome was the presence of a cesarean scar defect. Additional ultrasound measurements were used to evaluate the morphology of the cesarean scar and residual myometrial thickness.
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
- Single (Outcomes Assessor)
盲法说明
The investigator performing the postpartum transvaginal ultrasonography and assessing the uterine scar was blinded to treatment allocation. Participants were instructed not to disclose their assigned uterine closure technique to the outcome assessor.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-45 years Undergoing first cesarean delivery Early-term, term, or post-term pregnancy Elective or emergency indication for cesarean delivery Provided written informed consent
排除标准
- •Previous cesarean delivery Congenital uterine anomaly Chronic anemia Uncontrolled gestational or pregestational diabetes mellitus Uncontrolled hypertension Severe preeclampsia Body mass index >30 kg/m² Active labor lasting >5 hours Cervical dilatation >5 cm at cesarean delivery
研究组 & 干预措施
Double-Layer Nonlocking Uterine Closure
Participants underwent uterine incision closure using a double-layer, incision-parallel, nonlocking continuous suturing technique.
干预措施: Double-Layer Incision-Parallel Nonlocking Uterine Closure (Procedure)
Single-Layer Locked Uterine Closure
Participants underwent uterine incision closure using a single-layer locked continuous suturing technique.
干预措施: Single-Layer Locked Uterine Closure (Procedure)
结局指标
主要结局
Incidence of Cesarean Scar Defect
时间窗: At least 3 months after cesarean delivery
Cesarean scar defect (CSD) was assessed by transvaginal ultrasonography and defined as a visible hypoechoic indentation at the site of the cesarean scar with a depth of at least 2 mm.
次要结局
- Cesarean Scar Morphometric Measurements(At least 3 months after cesarean delivery)
- Perioperative Hemoglobin Change(From preoperative assessment to postoperative day 1.)
研究者
Onur Karaaslan
Associate Professor of Obstetrics and Gynecology
Yuzuncu Yil University