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Completed

NCT Number: NCT02842177

Evaluation of a Novel Technique for Intrauterine Contraceptive Devices Insertion

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.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Transvaginal ultrasound

Radiation

Cu-IUD

Device

Primary outcomes

  1. Successful intrauterine device insertion

    Time frame: 5 minutes

    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

Secondary outcomes

  1. The degree of pain during intrauterine device insertion

    Time frame: 5 minutes

    measured by Visual Analog Pain Scale

  2. the duration of intrauterine device insertion

    Time frame: 5 minutes

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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2016
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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