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

Gaziosmanpasa Research and Education Hospital

Status: Completed

Conditions: Isthmocele; Pelvic Pain; Post-menstrual Spotting Bleeding

Treatments: Drug: Levonorgestrel Drug Implant Product; Device: usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele

Study type: Interventional

Funder types: Other

Identifiers

NCT04872244

GaziosmanpasaTREHB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 30 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Device: usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele

Drug: Levonorgestrel Drug Implant Product