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

Assiut University

Status and phase: Completed; Phase 2

Conditions: Contraception

Treatments: Other: IUD; Radiation: Transvaginal ultrasound; Other: Uterine sounding

Study type: Interventional

Funder types: Other

Identifiers

NCT02841826

PIUD

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Group I: IUD without uterine sound group

Other group

Description:

Transvaginal ultrasound before to intrauterine contraceptive device insertion without uterine sounding.

Treatment:

Other: IUD

Radiation: Transvaginal ultrasound

Group II: IUD with uterine sound

Other group

Description:

Intrauterine contraceptive device inserted by classic method

Treatment:

Other: Uterine sounding

Other: IUD