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临床试验/NCT04872244
NCT04872244已完成不适用

Results of Intrauterine Levonorgestrel Use for the Patients With Isthmocele Suffering From Postmenstrual Spotting Without Fertility Desire

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年11月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
incidence of pelvic pain

研究概览

简要总结

it was planned to investigate the treatment effect of levonorgestrel releasing intrauterine device in patient with isthmocele who were suffering from postmenstrual spotting bleeding and who had no desire for fertility.

详细描述

isthmocele is an acquired diverticulum like defect of myometrium in the anterior isthmic part of uterus due to previous cesarean section incision. It can be defined as thinning of the incised site of uterus smaller than 50 % of its normal thickness. the real incidence is unknown. due to low ability of contractility of the postmenstrual spotting bleeding. Accumulation of blood in the isthmocele induces inflammation within the endometrium and causes pain as well. Furthermore, this inflammation can be an absolute reason for secondary infertility. As a result, accumulation of blood in the isthmocele seems to start up the cascade of morbidities. When understanding the mechanism, preventing blood accumulation seems to prevent symptoms other than infertility. Levonorgestrel releasing intrauterine devices can be a way of thinning the endometrium hence, blood accumulation can be avoided. In the literature, surgical correction of the isthmocele has been studied and medical treatment that was mentioned in the literature was the oral contraceptives and only a preliminary report of very small sample size, discussed the effect of levonorgestrel releasing device . in the light of aforementioned clinical knowledge, we planned to investigate the treatment effect of levonorgestrel releasing intrauterine device in patients with postmenstrual bleeding due to isthmocele who were not willing to have baby. These patients will be called back at 6th, 12th and 18th months after applying levonorgestrel releasing device to the uterus. Gynecological examinations will be done and complainants will be questioned.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • having isthmocele and complaining for postmestrual spotting bleeding
  • having cesarean section as a last delivery way.
  • not planning for fertility
  • complaining about dysmenorrhea and pelvic pain

排除标准

  • having pelvic infection
  • having an any type of previous pelvic surgery
  • having leiomyoma, endometrial polyp or adnexal mass
  • having any type of malignancy
  • having thyroid dysfunction and prolactinemia

研究组 & 干预措施

patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied

Experimental

outcome measures of patients suffering from postmenstruel spotting due to ısthmosele whom mirena ( levonorgestrel releasing intrauterine device) was applied

干预措施: usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele (Device)

patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied

Experimental

outcome measures of patients suffering from postmenstruel spotting due to ısthmosele whom mirena ( levonorgestrel releasing intrauterine device) was applied

干预措施: Levonorgestrel Drug Implant Product (Drug)

结局指标

主要结局

incidence of pelvic pain

时间窗: 18 months

incidence of pelvic pain regardless of mensturation

incidence of postmenstrual spotting bleeding

时间窗: 18 months

incidence of vaginal spotting bleeding after normal menstrual bleeding

incidence of dysmenorrhea

时间窗: 18 months

incidence of pelvic pain felt by the patient during mensturation

次要结局

未报告次要终点

研究者

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

Fatma ketenci gencer

Dr.

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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