Can Intrauterine Levonorgestrel Releasing Device Be a Treatment Option for Postmenstrual Spotting in Isthmocele

Overview

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.

Full Title of Study: “Results of Intrauterine Levonorgestrel Use for the Patients With Isthmocele Suffering From Postmenstrual Spotting Without Fertility Desire”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 3, 2021

Detailed Description

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.

Interventions

  • Device: usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele
    • usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele for postmenstrual spotting and do not have desire for fertility
  • Drug: Levonorgestrel Drug Implant Product
    • intrauterine administration

Arms, Groups and Cohorts

  • Experimental: patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied
    • outcome measures of patients suffering from postmenstruel spotting due to ─▒sthmosele whom mirena ( levonorgestrel releasing intrauterine device) was applied

Clinical Trial Outcome Measures

Primary Measures

  • incidence of postmenstrual spotting bleeding
    • Time Frame: 18 months
    • incidence of vaginal spotting bleeding after normal menstrual bleeding
  • incidence of dysmenorrhea
    • Time Frame: 18 months
    • incidence of pelvic pain felt by the patient during mensturation
  • incidence of pelvic pain
    • Time Frame: 18 months
    • incidence of pelvic pain regardless of mensturation

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

  • 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

Gender Eligibility: Female

Minimum Age: 30 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gaziosmanpasa Research and Education Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • fatma ketenci Gencer, MD, 5416116469, fathma_k@hotmail.com

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