Levonorgestrel-releasing Intrauterine System and Tubal Ligation

NCT ID: NCT04663568

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-12-01

Brief Summary

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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

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Conditions

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Tubal Ligation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levonorgestrel-releasing intrauterine system

Group Type OTHER

Levonorgestrel-releasing intrauterine system

Intervention Type DEVICE

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

Interventions

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Levonorgestrel-releasing intrauterine system

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Khairy Ali

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Women Health Hospital - Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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LNG_TS

Identifier Type: -

Identifier Source: org_study_id

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