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Simplified IUD Insertion Technique (SIIT)

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Recruitment Status : Withdrawn (Lack of funding)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

Tracking Information
First Submitted Date  ICMJE February 9, 2016
First Posted Date  ICMJE April 11, 2016
Last Update Posted Date February 6, 2020
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Simplified IUD Insertion Technique
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE Procedure: Simplified IUD Insertion
IUD Insertion with no bimanual pelvic exam or uterine sounding.
Study Arms  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 4, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2016)
440
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02733081
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Paul D Blumenthal, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul D Blumenthal, MD, MPH Stanford University
PRS Account Stanford University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP