Long Term Comparison of Double Layer Continuously Locked Closure of Uterine Incision in Cesarean Section Versus Double Layer Purse String Closure (Turan Technique): A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Placenta Previa
研究概览
简要总结
Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies, ...) are very important issues. Classically Kerr incision is repaired with continuous locked suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in turn may reduce short and long term complications. For this reason, the investigators aimed to compare two closure techniques.
详细描述
In the clinic, patients undergoing cesarean section that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups (computer-assisted randomization method will be used.) In the first group of patients classical closure method of Kerr incision(double layered continuously locked suturing) will be used. In the second group of patients double layered purse string closure technique will be used.
Women will be followed for a subsequent pregnancy in the next average 6 years. If they become pregnant again they will be followed up during pregnancy for comparison of long-term effects of the two suture techniques. Patients will be followed especially from the aspects of placental anomalies. Presence of intra-abdominal adhesions, uterine dehiscence, placenta previa, placental invasion anomalies (eg, placenta accreta and others)and incomplete or complete rupture will be compared between two groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy
- •Term (> 37 weeks) pregnancy
- •Cervical dilatation < 4 cm
- •Kerr incision
- •Age > 18 years old
排除标准
- •Being in active phase of labor
- •Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa )
- •Having a history of uterine surgery (myomectomy, hysterotomy) other than CS
- •Extension of Kerr incision
- •Multiple pregnancy
- •Maternal diabetes mellitus
- •Maternal connective tissue disease
- •Uterine malformation
- •Uterine fibroids on Kerr incision line
- •Chorioamnionitis
结局指标
主要结局
Placenta Previa
时间窗: Subsequent pregnancy within next average 6 years
It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.
次要结局
- Placenta Insertion Anomalies(Subsequent pregnancy within next average 6 years)
- Intra-abdominal Adhesions(Up to average 6 years)
- Uterine Rupture(Subsequent pregnancy within next average 6 years)
研究者
Mehmet Cem Turan
Chief Clinical
Dr. Lutfi Kirdar Kartal Training and Research Hospital