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NCT Number: NCT06554249

Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance

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 .

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Key information

Conditions

Contraceptive Device Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Cairo university

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women requesting IUD insertion

Exclusion criteria

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

Treatment and study plan

Vulsellum group

Procedure

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

Procedure

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 outcomes

  1. Intensity of pain

    Time frame: Immediately after the procedure

    Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)

Secondary outcomes

  1. Success of IUD insertion

    Time frame: Immediately after the procedure

    ( number of successfully inserted IUD / total number of IUD insertion attempts)

Study contacts

Contact information is provided by the study sponsor or research team.

Usama M Fouda, Prof.

CONTACT

[email protected]

01095401375 ext. +2

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Bedaya Hospital

Registry information

Official study title

Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance Versus the Standard Technique for IUD Insertion

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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