Evaluation of a Novel and Simplified Technique for Intrauterine Contraceptive Devices Insertion: a Prospective Cohort Study
NCT ID: NCT02841826
Last Updated: 2016-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2016-01-31
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The fear and the pain associated with IUDs insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia.
The pain during IUDs insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the IUDs through the cervix, and irritation of the endometrial lining by the IUDs.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group I: IUD without uterine sound group
Transvaginal ultrasound before to intrauterine contraceptive device insertion without uterine sounding.
IUD
Transvaginal ultrasound
Group II: IUD with uterine sound
Intrauterine contraceptive device inserted by classic method
IUD
Uterine sounding
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IUD
Uterine sounding
Transvaginal ultrasound
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Women accepted participation in the study
Exclusion Criteria
* Endometrial lesions as polyp
* Adenomyosis
* Fibroids distorting the cavity
* Intrauterine adhesions.
* Chronic pelvic pain
* Dysmenorrhea
* History of cervical surgery
20 Years
40 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohammed Khairy Ali
Dr
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Women Health Hospital - Assiut university
Asyut, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PIUD
Identifier Type: -
Identifier Source: org_study_id