Evaluation of a Novel Technique for Intrauterine Contraceptive Devices Insertion

• ClinicalTrials.gov Identifier: NCT02842177
• Recruitment Status: Completed
• First Posted: July 22, 2016
• Last Update Posted: March 28, 2017
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mohammed Khairy Ali, Assiut University

Tracking Information

• First Submitted Date: July 15, 2016
• First Posted Date: July 22, 2016
• Last Update Posted Date: March 28, 2017
• Actual Study Start Date: January 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 26, 2017)

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

• Original Primary Outcome Measures (submitted: July 20, 2016): The degree of total pain perception during intrauterine contraceptive insertion measured by visual analogue scale [ Time Frame: 6 months ]

Current Secondary Outcome Measures (submitted: March 26, 2017)

• The degree of pain during intrauterine device insertion [ Time Frame: 5 minutes ]
  measured by Visual Analog Pain Scale
• the duration of intrauterine device insertion [ Time Frame: 5 minutes ]
  The time between start of IUD insertion and the end of the procedure

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of a Novel Technique for Intrauterine Contraceptive Devices Insertion
• Official Title: Classic vs. Uterine Sound-sparing Approach for Insertion of Copper T380A Intrauterine Device

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: 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.
• Procedure: 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

Study Arms

• Active Comparator: Group I (classic method)
  Interventions:

  • Procedure: Classic group
  • Device: Cu-IUD
• Active Comparator: uterine sound sparing group
  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 26, 2017): 92
• Original Estimated Enrollment (submitted: July 20, 2016): 200
• Actual Study Completion Date: September 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT02842177
• Other Study ID Numbers: NIUD
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: Mohammed Khairy Ali, Assiut University
• Original Responsible Party: Same as current
• Current Study Sponsor: Assiut University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: March 2017