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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Pain; Isthmocele; Post-menstrual Spotting Bleeding
• Intervention / Treatment: Device: usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele; Drug: Levonorgestrel Drug Implant Product

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34245
    • saglik Bilimleri Univercity Gaziosmanpaşa Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: levonorgestrel; Drug: Levonorgestrel Drug Implant Product; intrauterine administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postmenstrual spotting bleeding	incidence of vaginal spotting bleeding after normal menstrual bleeding	18 months
incidence of dysmenorrhea	incidence of pelvic pain felt by the patient during mensturation	18 months
incidence of pelvic pain	incidence of pelvic pain regardless of mensturation	18 months

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2019
• Primary Completion (Actual): June 3, 2021
• Study Completion (Actual): July 12, 2021

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 22, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: pelvic pain; isthmocele; postmenstrual spotting bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Uterine Diseases; Uterine Hemorrhage; Hemorrhage; Metrorrhagia; Pelvic Pain; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: GaziosmanpasaTREHB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes