Effect of the Baseball Suturing Technique on the Incidence of Isthmocele and Residual Myometrial Thickness After Cesarean: 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
- 80
- 试验地点
- 1
- 主要终点
- Measurement of residual myometrial thickness
研究概览
简要总结
Cesarean delivery rates in Turkey as well as all over the world are increasing. Recent data in Turkey shows that the value of cesarean delivery rate reached 53%. This worldwide increase causes new concerns. Incomplete healing of the uterine scar after cesarean is a complication with potential long-term consequences. There is evidence that the risk of uterine scar defects is associated with the number of previous cesarean deliveries and the method of uterotomy closure. Study was designed as prospective randomized clinical trial to analyze the effects of two different uterine suture techniques. The investigators aim is to compare the closure of the incision with the "baseball" suture technique and the single-layer locking technique in terms of the incidence and depth of the isthmocele in the uterine incision scar as a short-term result.
详细描述
This study was designed as a double-blind randomized prospective and cross-sectional. Cesarean delivery planned patients who will admit to the Obstetrics and Gynecology Clinic, Tokat Gaziosmanpasa University Research and Application Center between January 2021 and June 2021 will be evaluated. Participation of the patients in the study will be based on written consents. All patients who meet the inclusion criteria will be randomized into two groups (i.e., "baseball" or single layer locked).
This study was approved by Tokat Gaziosmanpasa University Institutional Review Board and Ethics Committee (Project no= 20-KAEK-311, Approval Date= 12/17/2020).
Pregnant women who are over 37 weeks, have no pregnancy complications, and will undergo uterine surgery for the first time will be included in the study. Exclusion criteria are determined as: Preoperative hemogram value below 10mg/dL, active labor (regular contraction and> 4cm cervical opening), placental anomaly, previous uterine surgery, chorioamnionitis, premature rupture of membranes, additional disease, body mass index BMI> 35kg / m2, consuming tobacco and / or alcohol, needing blood transfusion and multiple pregnancy.
Randomization will be created on a computer controlled by a statistician to create two groups. Before cesarean delivery, sealed, opaque and numbered envelope containing the definition and image of the suture technique will be reported to the surgeon. Participants included in the study 3 months after the operation will be called for control by an external observer. Follow-up data and ultrasound measurements of uterine incision scar area will be documented by sonographer who does not know the uterotomy closure technique applied to the patient.
During the follow up examination, weight and breastfeeding status of the patient and ultrasound measurement of uterine length, uterine position, residual myometrial thickness, isthmocele depth, isthmocele width, cervical thickness, isthmocele fundus distance, isthmocele cervical distance, hypoechoic isthmocele width in transverse plane will be recorded.
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
- •Women undergoing their first cesarean section
- •After 37 gestational week pregnancy
- •Have no pregnancy complications
排除标准
- •Preoperative hemogram value below 10mg / dl
- •Active labor (regular contraction and> 4cm cervical opening)
- •Placental anomaly
- •Previous uterine surgery
- •Chorioamnionitis
- •Premature rupture of membranes
- •Additional disease will affect tissue healing
- •Body mass index BMI> 35kg / m2
- •Consuming tobacco and / or alcohol
- •Needing blood transfusion
- •Multiple pregnancy
研究组 & 干预措施
Uterine closure with "Baseball" suture technique
Participants will undergo "Baseball" suture closure of the hysterotomy site at the time of cesarean section.
干预措施: Uterine closure with "Baseball" suture technique (Procedure)
Single Layer Continuous Locked
Participants will undergo Single Layer Continuous Locked suture closure of the hysterotomy site at the time of cesarean section.
干预措施: Single Layer Continuous Locked (Procedure)
结局指标
主要结局
Measurement of residual myometrial thickness
时间窗: 3 months
Measurement of residual myometrial thickness on a transvaginal ultrasound 3 months after the cesarean section
Presence of isthmocele
时间窗: 3 months
The presence of an isthmocele (minimum 2 mm x 2 mm) identified on a transvaginal ultrasound 3 months after the cesarean section
次要结局
- Measurement of uterus(3 months)
- Additional hemostatic sutures(Through the surgery completion, an average of 30 minutes)
- Operation time(Through the surgery completion, an average of 30 minutes)
- Changes in Hemoglobin(24 hours)
研究者
İlhan Bahri Delibas
Tokat Gaziosmanpasa University, Head of Gynecology and Obstetrics Department
Tokat Gaziosmanpasa University