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

Primary Purpose

Isthmocele, Post-menstrual Spotting Bleeding, Pelvic Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele
Levonorgestrel Drug Implant Product
Sponsored by
Gaziosmanpasa Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Isthmocele focused on measuring isthmocele, postmenstrual spotting bleeding, pelvic pain

Eligibility Criteria

30 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • saglik Bilimleri Univercity Gaziosmanpaşa Training and Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

incidence of postmenstrual spotting bleeding
incidence of vaginal spotting bleeding after normal menstrual bleeding
incidence of dysmenorrhea
incidence of pelvic pain felt by the patient during mensturation
incidence of pelvic pain
incidence of pelvic pain regardless of mensturation

Secondary Outcome Measures

Full Information

First Posted
June 15, 2020
Last Updated
August 22, 2021
Sponsor
Gaziosmanpasa Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04872244
Brief Title
Can Intrauterine Levonorgestrel Releasing Device Be a Treatment Option for Postmenstrual Spotting in Isthmocele
Official Title
Results of Intrauterine Levonorgestrel Use for the Patients With Isthmocele Suffering From Postmenstrual Spotting Without Fertility Desire
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 3, 2019 (Actual)
Primary Completion Date
June 3, 2021 (Actual)
Study Completion Date
July 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Isthmocele, Post-menstrual Spotting Bleeding, Pelvic Pain
Keywords
isthmocele, postmenstrual spotting bleeding, pelvic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients who have isthmocele due to previous cesarean section and suffering from postmenstrual spotting bleeding
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied
Arm Type
Experimental
Arm Description
outcome measures of patients suffering from postmenstruel spotting due to ısthmosele whom mirena ( levonorgestrel releasing intrauterine device) was applied
Intervention Type
Device
Intervention Name(s)
usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele
Other Intervention Name(s)
levonorgestrel
Intervention Description
usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele for postmenstrual spotting and do not have desire for fertility
Intervention Type
Drug
Intervention Name(s)
Levonorgestrel Drug Implant Product
Intervention Description
intrauterine administration
Primary Outcome Measure Information:
Title
incidence of postmenstrual spotting bleeding
Description
incidence of vaginal spotting bleeding after normal menstrual bleeding
Time Frame
18 months
Title
incidence of dysmenorrhea
Description
incidence of pelvic pain felt by the patient during mensturation
Time Frame
18 months
Title
incidence of pelvic pain
Description
incidence of pelvic pain regardless of mensturation
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
saglik Bilimleri Univercity Gaziosmanpaşa Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34245
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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