Intrauterine Device Insertion: a Step for High Satisfaction
Condition: Intrauterine Device
Study type: Interventional

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.
    


Intervention name(s): Intrauterine device; Ultrasound; uterine sounding sparing technique
Intervention type(s): Device; Radiation; Procedure
Intervention description(s): Copper T 380 A; Transabdominal ultrasound; we will insert intrauterine device without using the uterine sound and we will replace this step by ultrasound before insertion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention