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

Pelvic Pain Clinical Trial

Official title:

Results of Intrauterine Levonorgestrel Use for the Patients With Isthmocele Suffering From Postmenstrual Spotting Without Fertility Desire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04872244
• Other study ID #: GaziosmanpasaTREHB
• Status: Completed
• Phase: N/A
• Start date: November 3, 2019
• Est. completion date: July 12, 2021

Study information

• Verified date: June 2020
• Source: Gaziosmanpasa Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 12, 2021
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Isthmocele
• Metrorrhagia
• Pelvic Pain

Intervention

Device:
• 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

Drug:
• Levonorgestrel Drug Implant Product
intrauterine administration

Locations

Country	Name	City	State
Turkey	saglik Bilimleri Univercity Gaziosmanpasa Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postmenstrual spotting bleeding	incidence of vaginal spotting bleeding after normal menstrual bleeding	18 months
Primary	incidence of dysmenorrhea	incidence of pelvic pain felt by the patient during mensturation	18 months
Primary	incidence of pelvic pain	incidence of pelvic pain regardless of mensturation	18 months