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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-03

Study Completion Date

2021-07-12

Brief Summary

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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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Detailed Description

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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.

Conditions

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Isthmocele Post-menstrual Spotting Bleeding Pelvic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

patients who have isthmocele due to previous cesarean section and suffering from postmenstrual spotting bleeding

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele

Intervention Type DEVICE

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

Levonorgestrel Drug Implant Product

Intervention Type DRUG

intrauterine administration

Interventions

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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

Intervention Type DEVICE

Levonorgestrel Drug Implant Product

intrauterine administration

Intervention Type DRUG

Other Intervention Names

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levonorgestrel

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No