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Completed

NCT Number: NCT04872244

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

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.

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Key information

Age range

30 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

saglik Bilimleri Univercity Gaziosmanpaşa Training and Research Hospital

Istanbul, 34245, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele

Device

usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele for postmenstrual spotting and do not have desire for fertility

Other names: levonorgestrel

Levonorgestrel Drug Implant Product

Drug

intrauterine administration

Primary outcomes

  1. incidence of postmenstrual spotting bleeding

    Time frame: 18 months

    incidence of vaginal spotting bleeding after normal menstrual bleeding

  2. incidence of dysmenorrhea

    Time frame: 18 months

    incidence of pelvic pain felt by the patient during mensturation

  3. incidence of pelvic pain

    Time frame: 18 months

    incidence of pelvic pain regardless of mensturation

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 4, 2021
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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