Evaluation of a Novel Technique for Intrauterine Contraceptive Devices Insertion

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842177
• Other study ID #: NIUD
• Status: Completed
• Phase: N/A
• First received: July 15, 2016
• Last updated: March 26, 2017
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women requesting intrauterine contraceptive device as a contraction

Exclusion Criteria:

• Uterine abnormalities

• Endometrial lesions,

• Adenomyosis

• Fibroids

• Intrauterine adhesions.

• Chronic pelvic pain

• Spasmodic dysmenorrhea

• History of cervical surgery

Related Conditions & MeSH terms

• Contraception

Intervention

Procedure:
• Classic group
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.
• Uterine sounding sparing group
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.

Radiation:
• Transvaginal ultrasound

Device:
• Cu-IUD

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful intrauterine device insertion	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	5 minutes
Secondary	The degree of pain during intrauterine device insertion	measured by Visual Analog Pain Scale	5 minutes
Secondary	the duration of intrauterine device insertion	The time between start of IUD insertion and the end of the procedure	5 minutes