Contraceptive Device
Conditions
Keywords
IUD, Ultrasound, Full bladder, Pain
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.
Interventions
PROCEDUREVulsellum 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.
PROCEDUREUltrasound 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..
Sponsors
Bedaya Hospital
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No
Inclusion criteria
* Women requesting IUD insertion
Exclusion criteria
* Active pelvic infection * Viable intrauterine pregnancy * Uterine anomalies * Uterine fibroid * Wilson disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of pain | Immediately after the procedure | Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success of IUD insertion | Immediately after the procedure | ( number of successfully inserted IUD / total number of IUD insertion attempts) |
Countries
Egypt
Contacts
Primary ContactUsama M Fouda, Prof.
Outcome results
None listed