Evaluation of a Novel and Simplified Technique for Intrauterine Contraceptive Devices Insertion: a Prospective Cohort Study

Contraception Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841826
• Other study ID #: PIUD
• Status: Completed
• Phase: Phase 2
• First received: July 20, 2016
• Last updated: November 23, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Assiut Medical School Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women requesting intrauterine contraceptive device as a contraction

• Women accepted participation in the study

Exclusion Criteria:

• Uterine abnormalities

• Endometrial lesions as polyp

• Adenomyosis

• Fibroids distorting the cavity

• Intrauterine adhesions.

• Chronic pelvic pain

• Dysmenorrhea

• History of cervical surgery

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Other:
• IUD

• Uterine sounding

Radiation:
• Transvaginal ultrasound

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of pain perception measured visual analogue score		15 minutes	Yes