Levonorgestrel-releasing Intrauterine System and Tubal Ligation

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04663568

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tubal Ligation	Device: Levonorgestrel-releasing intrauterine system	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Levonorgestrel-releasing intrauterine system	Device: Levonorgestrel-releasing intrauterine system Levonorgestrel-releasing intrauterine system will be inserted during the menstrual cycle

Arm

Intervention/Treatment

Other: Levonorgestrel-releasing intrauterine system

Device: Levonorgestrel-releasing intrauterine system

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

Outcome Measures

Primary Outcome Measures

The level of pain from before to 6 months after levonorgestrel-releasing intrauterine system insertion [6 months]
It will be measured by visual analogue scale from 0 to 10

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women Health Hospital - Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammed Khairy Ali, Assistant professor, Assiut University

ClinicalTrials.gov Identifier:

NCT04663568

Other Study ID Numbers:

LNG_TS

First Posted:

Dec 11, 2020

Last Update Posted:

Dec 11, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Levonorgestrel

Study Results

No Results Posted as of Dec 11, 2020