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Simplified IUD Insertion Technique (SIIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Lack of funding)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

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.

Condition or disease Intervention/treatment Phase
Contraception Procedure: Simplified IUD Insertion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Simplified IUD Insertion Technique: A Randomized Controlled Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
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.
Procedure: Simplified IUD Insertion
IUD Insertion with no bimanual pelvic exam or uterine sounding.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Patient Satisfaction with IUD Insertion [ Time Frame: Immediately Post-Insertion ]
    Visual Analogue Scale (VAS)

  3. Patient Pain Scores (VAS) [ Time Frame: Immediately Post-Insertion ]
    Visual Analogue Scale (VAS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733081


Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Paul D Blumenthal, MD, MPH Stanford University
Publications:
Christensen K, et al. Simplifying Insertion of IUD Devices. Selected for poster presentation at FIGO 2015, Vancouver British Columbia.

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Responsible Party: Paul D Blumenthal, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02733081    
Other Study ID Numbers: IRB-35138
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul D Blumenthal, Stanford University:
Long Acting Reversible Contraception
Intrauterine Device (IUD)
Intrauterine Device (IUD) Insertion
Family Planning
International Family Planning