Levonorgestrel-releasing Intrauterine System and Tubal Ligation

Tubal Ligation Clinical Trial

Official title:

Levonorgestrel-releasing Intrauterine System: A Emerging Tool for Conservative Treatment of Pain and Bleeding After Tubal Ligation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04663568
• Other study ID #: LNG_TS
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Today tubal sterilization is a simple, safe, and cost-effective method of achieving long-term contraception. Sterilization is an ideal method of permanent contraception in developing countries where access to health care providers is limited. The percentage of women who use sterilization as a method of contraception rises from about 5% between 20 and 24 years of age to almost 50% for those between 40 and 44 years of age. The most widely touted and most significant health benefit of tubal sterilization appears to be a reduced risk of ovarian cancer.

Post-tubal ligation syndrome includes pain during intercourse, aching lower back, premenstrual tension syndrome, uterine hemorrhage, and absence of menstruation. The syndrome is caused by blood circulation problems in and around the Fallopian tubes and ovaries, pressure on nerves, and intrapelvic adhesion. Since the symptoms of this syndrome are mild, simple symptomatic treatment is sufficient in most cases. In some cases, however, hysterectomy may be necessary.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women aged from 30-40 year

• Woman subjected to tubal ligation

• Women 12 month postpartum

• Non lactating women

• Nomedical disorders

Exclusion Criteria:

• contraindication for Levonorgestrel-releasing Intrauterine System

• Women with any uterine or ovarian pathology

• women refuse to participate

Related Conditions & MeSH terms

• Tubal Ligation

Intervention

Device:
• Levonorgestrel-releasing intrauterine system
Levonorgestrel-releasing intrauterine system will be inserted during the menstrual cycle

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of pain from before to 6 months after levonorgestrel-releasing intrauterine system insertion	visual analogue scale from 0 (minimum value) to 10 (maximum value)	6 months