Evaluation of a Novel Technique for Intrauterine Contraceptive Devices Insertion

NCT02842177 | Completed

• 1 other identifier: NIUD
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The degree of pain during intrauterine device insertion

  5 minutes

• the duration of intrauterine device insertion

  5 minutes

Study Arms (2)

Group I (classic method)

ACTIVE COMPARATOR

Procedure: Classic group; Device: Cu-IUD

uterine sound sparing group

ACTIVE COMPARATOR

Procedure: Classic group; Procedure: Uterine sounding sparing group; Radiation: Transvaginal ultrasound; Device: Cu-IUD

Interventions

Classic group PROCEDURE

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.

Group I (classic method); uterine sound sparing group

Uterine sounding sparing group PROCEDURE

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.

uterine sound sparing group

Transvaginal ultrasound RADIATION

uterine sound sparing group

Cu-IUD DEVICE

Group I (classic method); uterine sound sparing group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women requesting intrauterine contraceptive device as a contraction

You may not qualify if:

• Uterine abnormalities
• Endometrial lesions,
• Adenomyosis
• Fibroids
• Intrauterine adhesions.
• Chronic pelvic pain
• Spasmodic dysmenorrhea
• History of cervical surgery

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 22, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 28, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)