Evaluation of a Novel and Simplified Technique for Intrauterine Contraceptive Devices Insertion: a Prospective Cohort Study
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|ClinicalTrials.gov Identifier: NCT02841826|
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : November 25, 2016
The intrauterine devices (IUDs) are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years.
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.
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Other: IUD Other: Uterine sounding Radiation: Transvaginal ultrasound||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Group I: IUD without uterine sound group
Transvaginal ultrasound before to intrauterine contraceptive device insertion without uterine sounding.
Radiation: Transvaginal ultrasound
Group II: IUD with uterine sound
Intrauterine contraceptive device inserted by classic method
Other: Uterine sounding
- The degree of pain perception measured visual analogue score [ Time Frame: 15 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841826
|Women Health Hospital - Assiut university|
|Assiut, Egypt, 71111|