Levonorgestrel-releasing Intrauterine System and Tubal Ligation

Not Applicable

Terminated

• Conditions: Tubal Ligation
• Interventions: Device: Levonorgestrel-releasing intrauterine system

• Registration Number: NCT04663568
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2020-12-05
• Study First Submitted QC: 2020-12-05
• Study First Posted: 2020-12-11
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-26
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levonorgestrel-releasing intrauterine system	Levonorgestrel-releasing intrauterine system	-

Primary Outcome Measures

Name	Time	Method
The level of pain from before to 6 months after levonorgestrel-releasing intrauterine system insertion	6 months	visual analogue scale from 0 (minimum value) to 10 (maximum value)

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt