Evaluation of a Novel Technique for Intrauterine Contraceptive Devices Insertion

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Procedure: Classic group; Procedure: Uterine sounding sparing group; Radiation: Transvaginal ultrasound; Device: Cu-IUD

• Registration Number: NCT02842177
• Lead Sponsor: Assiut University

Brief Summary

The intrauterine devices 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 intrauterine devices 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 intrauterine devices insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the intrauterine devices through the cervix, and irritation of the endometrial lining by the intrauterine devices .

Previous studies have reported different lines to decrease pain during intrauterine device insertion starting by simple methods such as pre-insertion ibuprofen use, intracervical or intrauterine lidocaine and misoprostol up to paracervical blocks.

Previous studies, in literature, have found that the most painful steps during intrauterine devices insertion were uterine sounding then intrauterine device insertion itself, followed by tenaculum placement. One recent study addressed pain effect using an atraumatic vulsellum and a single-tooth tenaculum on pain perception during intrauterine devices and found no difference in reported pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-22
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-26
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

• Women requesting intrauterine contraceptive device as a contraction

Exclusion Criteria

• Uterine abnormalities
• Endometrial lesions,
• Adenomyosis
• Fibroids
• Intrauterine adhesions.
• Chronic pelvic pain
• Spasmodic dysmenorrhea
• History of cervical surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
uterine sound sparing group	Classic group	-
uterine sound sparing group	Transvaginal ultrasound	-
Group I (classic method)	Classic group	-
uterine sound sparing group	Cu-IUD	-
Group I (classic method)	Cu-IUD	-
uterine sound sparing group	Uterine sounding sparing group	-

Primary Outcome Measures

Name	Time	Method
Successful intrauterine device insertion	5 minutes	defined by a distance from the intrauterine device to the end of endometrial line of less than 25 mm The degree of total pain perception during intrauterine contraceptive insertion measured by visual analogue scale

Secondary Outcome Measures

Name	Time	Method
the duration of intrauterine device insertion	5 minutes	The time between start of IUD insertion and the end of the procedure
The degree of pain during intrauterine device insertion	5 minutes	measured by Visual Analog Pain Scale

Trial Locations

Locations (1)

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