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Recruitment Status : Withdrawn (Lack of funding)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
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Procedure: Simplified IUD Insertion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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)
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
|Principal Investigator:||Paul D Blumenthal, MD, MPH||Stanford University|