跳至主要内容
临床试验/NCT03851003
NCT03851003已完成不适用

The Influence of Endometrial Suturing During Cesarean Section on the Risk to Develop Uterine Scar Defect: A Randomized Control Study

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2019年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Number of participants with uterine scar defect six month post cesarean section

研究概览

简要总结

Caesarean section (CS) is the commonest major operation performed on women worldwide with progressively rising incidence. Consequently, long-term adverse sequelae due to uterine scar defect have been increasing. Given the association between uterine scar defect and gynecological symptoms, obstetric complications and potentially with subfertility, it is important to elucidate the etiology in order to develop preventive strategies. Surgical technique of uterine incision closure seems to be the most important determinant of defect formation. The aim of this prospective randomized study is to evaluate specifically the influence of inclusion versus exclusion of the endometrium during suturing the uterine incision on the risk to develop uterine scar defect.

详细描述

Caesarean section (CS) is the commonest major operation performed on women worldwide with progressively rising incidence. Consequently, long-term adverse sequelae due to uterine scar defect have been increasing. Common gynecological complains include chronic pelvic pain, dyspareunia, dysmenorrhea and postmenstrual spotting and infertility. Obstetric sequelae seem to be increasing such as cesarean scar ectopic pregnancy, placenta previa, and placenta accrete, all associated with major maternal morbidity and even mortality. Given the association between uterine scar defect and gynecological symptoms, obstetric complications and potentially with subfertility, it is important to elucidate the etiology in order to develop preventive strategies. Probable risk factors suggested are single-layer myometrium closure, multiple CSs and uterine retroflexion, however, surgical technique of uterine incision closure seems to be the most important determinant of defect formation. It is proposed that continuous, non-locking absorbable sutures in two layers, without including much of decidua and without undue tight (constricting) pulling of sutures are likely to result in good healing of uterine scar. The aim of this prospective randomized study is to evaluate specifically the influence of inclusion versus exclusion of the endometrium during suturing the uterine incision on the risk to develop uterine scar defect.

Material and Methods Prospective randomized single blinded study conducted in a single tertiary center. All women at term (≥37 weeks of gestation) with singleton pregnancy that are about to go threw cesarean section attending the pre- operative clinics, will be offered to participate in the study. After signing informed consent, women will be block randomized for one of two groups: A- uterine incision repair including suturing of the endometrium, B - uterine incision repair without including the endometrium. All operation will be performed by a single highly skilled obstetrician. All other stages of operations will be similar in both of the groups including: low segment incision, delivery of the fetus and the placenta, uterine revision, intraperitoneal uterine repair, use of stratafix thread in double layer suturing. Operative and post operative data will be collected from the medical files including: operation duration, estimated blood loss, operation complications ( hypotension, bladder gut or vascular perforation ) , post operative complications ( hemorrhage, endometritis, vascular - thromboembolic event, ileus ). All women will be invited to the gynecologic clinics six month post operation for vaginal sonographic evaluation of the uterine scar and for filling questionnaire concerning possibility of uterine scar defect ( spotting, pelvic pain, fertility abnormalities ).

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 (Participant)

盲法说明

Women will not know which arm they were allocated to

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Term pregnancy (≥37 weeks of gestation)
  • •Elective CS

排除标准

  • •Uterine scar
  • •Thrombophilia
  • •Dysmorphic uterus
  • •Connective tissue disorder

研究组 & 干预措施

Endometrial suturing

Experimental

Uterine incision repair including suturing of the endometrium

干预措施: Endometrial suturing (Procedure)

Endometrial suturing

Experimental

Uterine incision repair including suturing of the endometrium

干预措施: Vaginal ultrasonography (Device)

Endometrial suturing

Experimental

Uterine incision repair including suturing of the endometrium

干预措施: Questionnaire (Other)

Non - Endometrial suturing

Experimental

Uterine incision repair without suturing of the endometrium

干预措施: Non- endometrial suturing (Procedure)

Non - Endometrial suturing

Experimental

Uterine incision repair without suturing of the endometrium

干预措施: Vaginal ultrasonography (Device)

Non - Endometrial suturing

Experimental

Uterine incision repair without suturing of the endometrium

干预措施: Questionnaire (Other)

结局指标

主要结局

Number of participants with uterine scar defect six month post cesarean section

时间窗: Until six month post cesarean section, and through study completion, an average of 1 year

Uterine scar defect with residual myometrium thickness of less then 2.5 mm

次要结局

  • Spotting(Through study completion, an average of 1 year)
  • Abdominal pain(Through study completion, an average of 1 year)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Aya Mohr-Sasson

Principal Investigator

Sheba Medical Center

研究点 (1)

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