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

Not Applicable

Completed

• Conditions: Isthmocele; Pelvic Pain; Post-menstrual Spotting Bleeding
• Interventions: Device: usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele; Drug: Levonorgestrel Drug Implant Product

• Registration Number: NCT04872244
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

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.

Study Timeline

• Study Start: 2019-11-03
• Status Verified: 2020-06
• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-04
• Primary Completion: 2021-06-03
• Study Completion: 2021-07-12
• Last Update Submitted: 2021-08-22
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied	usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele	outcome measures of patients suffering from postmenstruel spotting due to ısthmosele whom mirena ( levonorgestrel releasing intrauterine device) was applied
patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied	Levonorgestrel Drug Implant Product	outcome measures of patients suffering from postmenstruel spotting due to ısthmosele whom mirena ( levonorgestrel releasing intrauterine device) was applied

Primary Outcome Measures

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

Trial Locations

Locations (1)

saglik Bilimleri Univercity Gaziosmanpaşa Training and Research Hospital; 🇹🇷 Istanbul, Turkey