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Clinical Trials/NCT04663568
NCT04663568TerminatedNot Applicable

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

Assiut University2 sites in 1 country2 target enrollmentStarted: December 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
2
Locations
2
Primary Endpoint
The level of pain from before to 6 months after levonorgestrel-releasing intrauterine system insertion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
30 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

The level of pain from before to 6 months after levonorgestrel-releasing intrauterine system insertion

Time Frame: 6 months

visual analogue scale from 0 (minimum value) to 10 (maximum value)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohammed Khairy Ali

Assistant professor

Assiut University

Study Sites (2)

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