Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance

Cairo University82 enrolled

Overview

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 .

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Contraceptive Device

Interventions

Vulsellum groupPROCEDURE

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 groupPROCEDURE

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..

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 48 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women requesting IUD insertion Exclusion Criteria: * Active pelvic infection * Viable intrauterine pregnancy * Uterine anomalies * Uterine fibroid * Wilson disease

Locations (1)

Faculty of medicine, Cairo university

Cairo, Egypt

Outcomes

Primary Outcomes

Intensity of pain

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

Time frame: Immediately after the procedure

Secondary Outcomes

Success of IUD insertion

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

Time frame: Immediately after the procedure

Central Contacts

Usama M Fouda, Prof.

CONTACT

01095401375 umfrfouda@kasralainy.edu.eg

Data from ClinicalTrials.gov

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