Simplified IUD Insertion Technique (SIIT)

• ClinicalTrials.gov Identifier: NCT02733081
• Recruitment Status: Withdrawn
• First Posted: April 11, 2016
• Last Update Posted: February 6, 2020
• Sponsor: Stanford University
• Information provided by (Responsible Party): Paul D Blumenthal, Stanford University

Tracking Information

• First Submitted Date: February 9, 2016
• First Posted Date: April 11, 2016
• Last Update Posted Date: February 6, 2020
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 4, 2016)

Correct IUD Placement Immediately Post-Insertion [ Time Frame: Immediately post-insertion ]

Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at time of insertion as visualized by transvaginal ultrasound.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 19, 2017)

• Correct IUD Placements 4-6 Weeks Post-Insertion [ Time Frame: 4-6 weeks post-insertion ]
  Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at 4-6 weeks after insertion as visualized by transvaginal ultrasound.
• Patient Satisfaction with IUD Insertion [ Time Frame: Immediately Post-Insertion ]
  Visual Analogue Scale (VAS)
• Patient Pain Scores (VAS) [ Time Frame: Immediately Post-Insertion ]
  Visual Analogue Scale (VAS)

Original Secondary Outcome Measures (submitted: April 4, 2016)

• Comparative IUD Location Immediately Post-Insertion [ Time Frame: Immediately post-insertion ]
  Comparative IUD location immediately after insertion (fundal, lower uterine segment, cervical, or abdominal) as defined by the measured distance from tip of IUD to endometrial verge.
• Correct IUD Placements 4-6 Weeks Post-Insertion [ Time Frame: 4-6 weeks post-insertion ]
  Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at 4-6 weeks after insertion as visualized by transvaginal ultrasound.
• Comparative IUD Location 4-6 Weeks Post-Insertion [ Time Frame: 4-6 weeks post-insertion ]
  Comparative IUD location 4-6 weeks after insertion (fundal, lower uterine segment, cervical, or abdominal) as defined by the measured distance from tip of IUD to endometrial verge.
• Change in IUD Location [ Time Frame: 4-6 weeks post-insertion ]
  Change in distance from tip of IUD to endometrial verge. 4-6 week follow-up measurements compared to initial measurement immediately post-insertion of IUD.
• Demographics [ Time Frame: Immediately Pre-Procedure ]
  Age, parity, prior IUD use, prior NSVD documented via questionnaire administered by study coordinator
• Patient Satisfaction with IUD Insertion [ Time Frame: Immediately Post-Insertion ]
  Visual Analogue Scale (VAS)
• Patient Pain Scores (VAS) [ Time Frame: Immediately Pre-Insertion ]
  Visual Analogue Scale (VAS)
• Patient Pain Scores (VAS) [ Time Frame: Immediately Post-Insertion ]
  Visual Analogue Scale (VAS)
• Instruments Needed for Insertion [ Time Frame: Immediately Post-Insertion ]
  Document if any instruments were needed for insertion in investigational group (os finder, uterine sound).
• Provider's Opinion of Ease of Insertion [ Time Frame: Immediately Post-Insertion ]
  Visual Analogue Scale (VAS)
• Provider's Reason for Failed Insertion [ Time Frame: Immediately Post-Insertion ]
  Only when applicable, documented via questionnaire administered by study coordinator

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

Descriptive Information

• Brief Title: Simplified IUD Insertion Technique
• Official Title: Simplified IUD Insertion Technique: A Randomized Controlled Trial
• Brief Summary: This is a randomized controlled trial that compares traditional IUD insertion with that of a no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD placement is safe and effective without pre-procedural assessment of uterine size, direction, or depth.
• 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: Simplified IUD Insertion

IUD Insertion with no bimanual pelvic exam or uterine sounding.

Study Arms

• No Intervention: Arm 1: Traditional IUD Insertion
  Standard IUD insertion according to package insert. Bimanual pelvic exam to assess uterine size and position will be performed. Uterine sound will be used to measure depth of uterus prior to insertion.
• Experimental: Arm 2: Simplified IUD Insertion
  Simplified, investigational IUD insertion performed. No bimanual pelvic exam or uterine sounding.
  Intervention: Procedure: Simplified IUD Insertion

Publications *

• Tayal VS, Crean CA, Norton HJ, Schulz CJ, Bacalis KN, Bliss S. Prospective comparative trial of endovaginal sonographic bimanual examination versus traditional digital bimanual examination in nonpregnant women with lower abdominal pain with regard to body mass index classification. J Ultrasound Med. 2008 Aug;27(8):1171-7.
• Padilla LA, Radosevich DM, Milad MP. Limitations of the pelvic examination for evaluation of the female pelvic organs. Int J Gynaecol Obstet. 2005 Jan;88(1):84-8.
• Maguire K, Davis A, Rosario Tejeda L, Westhoff C. Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception. 2012 Sep;86(3):214-9. doi: 10.1016/j.contraception.2012.01.005. Epub 2012 Feb 9.
• Canteiro R, Bahamondes MV, dos Santos Fernandes A, Espejo-Arce X, Marchi NM, Bahamondes L. Length of the endometrial cavity as measured by uterine sounding and ultrasonography in women of different parities. Contraception. 2010 Jun;81(6):515-9. doi: 10.1016/j.contraception.2010.01.006. Epub 2010 Mar 1.
• Bahamondes MV, Monteiro I, Canteiro R, Fernandes Ados S, Bahamondes L. Length of the endometrial cavity and intrauterine contraceptive device expulsion. Int J Gynaecol Obstet. 2011 Apr;113(1):50-3. doi: 10.1016/j.ijgo.2010.10.013. Epub 2011 Jan 26.
• Heinemann K, Reed S, Moehner S, Minh TD. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contraception.2015.01.007. Epub 2015 Jan 16.
• Christensen K, et al. Simplifying Insertion of IUD Devices. Selected for poster presentation at FIGO 2015, Vancouver British Columbia.
• ESHRE Capri Workshop Group. Intrauterine devices and intrauterine systems. Hum Reprod Update. 2008 May-Jun;14(3):197-208. doi: 10.1093/humupd/dmn003. Epub 2008 Apr 9. Review.

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: February 4, 2020): 0
• Original Estimated Enrollment (submitted: April 4, 2016): 440
• Estimated Study Completion Date: October 2020
• Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Women 18 years and older presenting to contraceptive clinic in Gaborone, Botswana for IUD insertion and have ability to give informed consent.

Exclusion Criteria:

• Known contradictions to copper IUD, inability to comply with study protocol

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02733081
• Other Study ID Numbers: IRB-35138
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Paul D Blumenthal, Stanford University
• Study Sponsor: Stanford University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Paul D Blumenthal, MD, MPH; Stanford University

• PRS Account: Stanford University
• Verification Date: February 2020