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临床试验/NCT04766567
NCT04766567已完成不适用

Long Term Obstetric, Perinatal and Surgical Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy

Bilge Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Complications of cesarean myomectomy

研究概览

简要总结

The present study aims to investigate whether there is a difference in short- and long-term complications in patients undergoing cesarean myomectomy (endometrial or serosal myomectomy) during cesarean section.

详细描述

Myomectomy is frequently performed during cesarean section. Infertility, myoma recurrence, adhesions , uterine rupture (complete/incomplete), impaired uterine healing (partial or complete dehiscence/poor/good), placental abnormalities, and perinatal complications in subsequent pregnancy are may be associated with cesarean myomectomy. In this study, patients who underwent cesarean myomectomy during cesarean section in our institute were analyzed in a retrospective manner. Patients were divided into three groups as those receiving serosal myomectomy, endometrial myomectomy and those who only underwent cesarean section. The groups were compared with respect to the presence of adhesion formation, time to achieve pregnancy (fertility), morphology of the myomectomy scar, presence of uterine rupture and placental abnormalities.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants should have singleton pregnancy delivered by cesarean section
  • Cesarean section technique should include: Transverse hysterotomy to enter the uterine cavity, single layer closure of the uterine wall, non-sutured visceral and parietal peritoneum
  • Myomectomy during cesarean section should include: only patients, who have undergone a single myomectomy and have been applied a single layer suture technique with the preservation of the pseudocapsule-for all cesarean myomectomy cases

排除标准

  • Patients having history of any malignancy
  • Patients with coagulation disorders
  • Patients with a history of previous intraabdominal surgery on reproductive organs
  • Patients with a history of endometriosis

结局指标

主要结局

Complications of cesarean myomectomy

时间窗: Post-cesarean 12 months

The difference in the rate of complications associated with the cesarean myomectomy (presence of adhesion formation, time to achieve pregnancy (fertility), morphology of the myomectomy scar, presence of uterine rupture and placental abnormalities) in patients undergoing endometrial myomectomy, serosal myomectomy, or not receiving myomectomy during cesarean section

次要结局

未报告次要终点

研究者

发起方
Bilge Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oguz Guler

Principle investigator

Bilge Hospital

研究点 (1)

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