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

Sponsor
Gaziosmanpasa Research and Education Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04872244
Collaborator
(none)
30
1
1
20.3
1.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele
  • Drug: Levonorgestrel Drug Implant Product
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
patients who have isthmocele due to previous cesarean section and suffering from postmenstrual spotting bleedingpatients who have isthmocele due to previous cesarean section and suffering from postmenstrual spotting bleeding
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Results of Intrauterine Levonorgestrel Use for the Patients With Isthmocele Suffering From Postmenstrual Spotting Without Fertility Desire
Actual Study Start Date :
Nov 3, 2019
Actual Primary Completion Date :
Jun 3, 2021
Actual Study Completion Date :
Jul 12, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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
Other Names:
  • levonorgestrel
  • Drug: Levonorgestrel Drug Implant Product
    intrauterine administration

    Outcome Measures

    Primary Outcome Measures

    1. incidence of postmenstrual spotting bleeding [18 months]

      incidence of vaginal spotting bleeding after normal menstrual bleeding

    2. incidence of dysmenorrhea [18 months]

      incidence of pelvic pain felt by the patient during mensturation

    3. incidence of pelvic pain [18 months]

      incidence of pelvic pain regardless of mensturation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 saglik Bilimleri Univercity Gaziosmanpaşa Training and Research Hospital Istanbul Turkey 34245

    Sponsors and Collaborators

    • Gaziosmanpasa Research and Education Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fatma ketenci gencer, Dr., Gaziosmanpasa Research and Education Hospital
    ClinicalTrials.gov Identifier:
    NCT04872244
    Other Study ID Numbers:
    • GaziosmanpasaTREHB
    First Posted:
    May 4, 2021
    Last Update Posted:
    Aug 25, 2021
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Fatma ketenci gencer, Dr., Gaziosmanpasa Research and Education Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2021