Clinical trial NCT04872244: 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
Overall status: COMPLETED
Phase: NA
Conditions: Isthmocele
Post-menstrual Spotting Bleeding
Pelvic Pain
Keywords: isthmocele
postmenstrual spotting bleeding
pelvic pain
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2021-05-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: patients who have isthmocele due to previous cesarean section and suffering from postmenstrual spotting bleeding
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: incidence of postmenstrual spotting bleeding
timeFrame: 18 months
measure: incidence of dysmenorrhea
timeFrame: 18 months
measure: incidence of pelvic pain
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: saglik Bilimleri Univercity Gaziosmanpaşa Training and Research Hospital
Study officials:
References: