Can Intrauterine Levonorgestrel Releasing Device Be a Treatment Option for Postmenstrual Spotting in Isthmocele
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied outcome measures of patients suffering from postmenstruel spotting due to ısthmosele whom mirena ( levonorgestrel releasing intrauterine device) was applied |
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
Other Names:
Drug: Levonorgestrel Drug Implant Product
intrauterine administration
|
Outcome Measures
Primary Outcome Measures
- 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
- incidence of pelvic pain [18 months]
incidence of pelvic pain regardless of mensturation
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | saglik Bilimleri Univercity Gaziosmanpaşa Training and Research Hospital | Istanbul | Turkey | 34245 |
Sponsors and Collaborators
- Gaziosmanpasa Research and Education Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GaziosmanpasaTREHB