Clinical Trial Summary
The intrauterine device is a safe, reliable and long-acting reversible contraceptive method.
Instrumentation of lower genital mucosa during intrauterine device application provokes pain
because it is highly sensitive to touch. Fear of pain associated with intrauterine device
insertion is considered a barrier to use this contraception method.
The classic insertion instructions recommend performing bimanual examination and uterine
sounding prior to intrauterine device insertion in order to confirm proper determination of
uterine size and position. The pain during intrauterine device insertion could be due to
cervical grasping by the tenaculum, traction on the cervical canal, stretching of the
internal os by the uterine sound or the intrauterine device inserter, and lastly by
irritation of the endometrial lining by the intrauterine device.
Many studies investigated the use of various analgesics in different doses and routes of
administration and found out that it has a significant impact on relieving of associated pain
Some technical modifications have been emerged in trial to decrease pain during intrauterine
device insertion. One of them is trans-abdominal ultrasound guided intrauterine device
insertion which the participant with a full bladder is subjected to intrauterine device
insertion under ultrasonographic guide without using tenaculum. This method effectively
decreased the pain and time of intrauterine device insertion.
A recent method named "Uterine Sounding Sparing Approach" has been reported very recently in
literature by Ali et al., 2017. In this method; the sonographer performs T transvaginal
ultrasound to evaluate the uterine position and the endometrial length in the sagittal view
of the uterus. The intrauterine device was inserted directly into the uterine cavity without
using uterine sounding.
In spite of less pain reported by trans-abdominal ultrasound guided intrauterine device
insertion (no vulsellum was used), this methods also have some drawbacks, firstly; the full
bladder may displace the cervix upward making the intrauterine device application not quite
easy and secondly; this method needs two investigators which may distress the women who
wondering about this. These two drawbacks may decrease patient's and physician's
satisfaction. The uterine sounding sparing approach lacks these two drawbacks which make it
more satisfying.
From above evidence, there is a strong need to compare the satisfaction rate between the two
mentioned approaches in trial to answer this question. Up to our knowledge; no randomized
trial has been conducted or registered to compare the satisfaction rate between two above
approaches.
