Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance

Not Applicable

Not yet recruiting

• Conditions: Contraceptive Device
• Interventions: Procedure: Vulsellum group; Procedure: Ultrasound group

• Registration Number: NCT06554249
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to determine whether full bladder IUD insertion without vulsellum or uterine sound under ultrasound guidance is associated with less pain compared with the standard technique of IUD insertion .

Detailed Description

The intrauterine device (IUD) is an effective method of contraception. Pain experienced during IUD insertion is one of the main causes that limits its widespread use.

Pain during IUD insertion is caused by insertion of cusco vaginal speculum, sounding the uterus, application of vulsellum to grasp the cervix, the passage of the inserter tube through the cervical canal and uterine cavity..

In order to minimize the pain associated with IUD insertion , several studies reported that the use of ultrasound to guide the insertion of IUD into uterine cavity was associated with less pain and more accurate placement of IUD, other studies reported that filling the bladder during IUD insertion minimized the pain associated with IUD insertion.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15
• Study Start: 2024-10-15
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• Women requesting IUD insertion

Exclusion Criteria

• Active pelvic infection
• Viable intrauterine pregnancy
• Uterine anomalies
• Uterine fibroid
• Wilson disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vulsellum group	Vulsellum group	The patients are asked to empty the bladder before IUD insertion. The vulsellum is applied on the cervix, sounding of the uterus is done and the IUD is inserted according to the standard technique of IUD insertion. Pain intensity is assessed after the procedure using a visual analogue scale.
Ultrasound group	Ultrasound group	During the two hour period before IUD insertion, the patients are asked to drink about one liter of water and to avoid micturition. Abdominal ultrasound is used to obtain a sagittal view of the uterus and the IUD is introduced into the uterine cavity under ultrasound guidance. The vulsellum and uterine sound are not used during IUD insertion. Pain intensity is assessed after the procedure using a visual analogue scale.

Primary Outcome Measures

Name	Time	Method
Intensity of pain	Immediately after the procedure	Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)

Secondary Outcome Measures

Name	Time	Method
Success of IUD insertion	Immediately after the procedure	( number of successfully inserted IUD / total number of IUD insertion attempts)

Trial Locations

Locations (1)

Faculty of medicine, Cairo university; 🇪🇬 Cairo, Egypt