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

Phase 2

Completed

• Conditions: Contraception
• Interventions: Other: IUD; Radiation: Transvaginal ultrasound; Other: Uterine sounding

• Registration Number: NCT02841826
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-22
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I: IUD without uterine sound group	IUD	Transvaginal ultrasound before to intrauterine contraceptive device insertion without uterine sounding.
Group I: IUD without uterine sound group	Transvaginal ultrasound	Transvaginal ultrasound before to intrauterine contraceptive device insertion without uterine sounding.
Group II: IUD with uterine sound	IUD	Intrauterine contraceptive device inserted by classic method
Group II: IUD with uterine sound	Uterine sounding	Intrauterine contraceptive device inserted by classic method

Primary Outcome Measures

Name	Time	Method
The degree of pain perception measured visual analogue score	15 minutes

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt