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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Dec 2020

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

December 1, 2020

Completed

4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed

Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

December 5, 2020

Last Update Submit

November 26, 2022

Conditions

Tubal Ligation

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)