SNPMiner Trials by Shray Alag

SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT02842177

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Classic vs. Uterine Sound-sparing Approach for Insertion of Copper T380A Intrauterine Device

The intrauterine devices are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years. The fear and the pain associated with intrauterine devices insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia. The pain during intrauterine devices insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the intrauterine devices through the cervix, and irritation of the endometrial lining by the intrauterine devices . Previous studies have reported different lines to decrease pain during intrauterine device insertion starting by simple methods such as pre-insertion ibuprofen use, intracervical or intrauterine lidocaine and misoprostol up to paracervical blocks. Previous studies, in literature, have found that the most painful steps during intrauterine devices insertion were uterine sounding then intrauterine device insertion itself, followed by tenaculum placement. One recent study addressed pain effect using an atraumatic vulsellum and a single-tooth tenaculum on pain perception during intrauterine devices and found no difference in reported pain.

NCT02842177 Contraception

4 Interventions

Name: Classic group

Description: The speculum was placed into the vagina and the cervix was cleansed with povidone iodine. After placement of single toothed vulsellum on the anterior lip of the cervix, for traction and fixation of the uterus, the uterine sound was inserted for determination of uterine length and uterine position followed by Cu-IUD insertion. The duration of IUD insertion were reported.

Type: Procedure

Group I (classic method) uterine sound sparing group

Name: Uterine sounding sparing group

Description: after bimanual examination, the same sonographer (Level II experience) performed transvaginal /US using a SonoAce X6 machine (Medison, Korea) with transvaginal probe (4-8 MHz frequency, using an average 6.5 MHz). Firstly, he evaluated the uterine position. Then, he measured the endometrial and cervical stripe lengths in the sagittal view of the uterus and summed to have the actual length of the uterus; by which the IUD tube was adjusted before insertion.The same speculum and vulsellum were used and the IUD was inserted directly into the uterine cavity.

Type: Procedure

uterine sound sparing group

Name: Transvaginal ultrasound

Type: Radiation

uterine sound sparing group

Name: Cu-IUD

Type: Device

Group I (classic method) uterine sound sparing group

Primary Outcomes

Description: defined by a distance from the intrauterine device to the end of endometrial line of less than 25 mm The degree of total pain perception during intrauterine contraceptive insertion measured by visual analogue scale

Measure: Successful intrauterine device insertion

Time: 5 minutes

Secondary Outcomes

Description: measured by Visual Analog Pain Scale

Measure: The degree of pain during intrauterine device insertion

Time: 5 minutes

Description: The time between start of IUD insertion and the end of the procedure

Measure: the duration of intrauterine device insertion

Time: 5 minutes

Purpose: Prevention

Allocation: Randomized

Parallel Assignment

There is one SNP


1 T380A

Classic vs. Uterine Sound-sparing Approach for Insertion of Copper T380A Intrauterine Device. --- T380A ---

HPO Nodes