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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04872244
Enrollment
30
Registered
2021-05-04
Start date
2019-11-03
Completion date
2021-07-12
Last updated
2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Isthmocele, Pelvic Pain, Post-menstrual Spotting Bleeding

Keywords

isthmocele, postmenstrual spotting bleeding, pelvic pain

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.

Interventions

DEVICEusage 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

DRUGLevonorgestrel Drug Implant Product

intrauterine administration

Sponsors

Gaziosmanpasa Research and Education Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of postmenstrual spotting bleeding18 monthsincidence of vaginal spotting bleeding after normal menstrual bleeding
incidence of dysmenorrhea18 monthsincidence of pelvic pain felt by the patient during mensturation
incidence of pelvic pain18 monthsincidence of pelvic pain regardless of mensturation

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026