Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance

Cairo University (CU)

Status: Not yet enrolling

Conditions: Contraceptive Device

Treatments: Procedure: Vulsellum group; Procedure: Ultrasound group

Study type: Interventional

Funder types: Other

Identifiers

NCT06554249

IUD/Ultrasound

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 82 estimated patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women requesting IUD insertion

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Vulsellum group

Active Comparator group

Description:

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.

Treatment:

Procedure: Vulsellum group

Ultrasound group

Active Comparator group

Description:

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.

Treatment:

Procedure: Ultrasound group