Results of Intrauterine Levonorgestrel Use for the Patients With Isthmocele Suffering From Postmenstrual Spotting Without Fertility Desire
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
- 否
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
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
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
Fatma ketenci gencer
Dr.
Gaziosmanpasa Research and Education Hospital
