Simplified IUD Insertion Technique | NCT02733081 | Trialant

Simplified IUD Insertion Technique | NCT02733081 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: Traditional IUD Insertion	No Intervention	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.
Arm 2: Simplified IUD Insertion	Experimental	Simplified, investigational IUD insertion performed. No bimanual pelvic exam or uterine sounding.	Procedure: Simplified IUD Insertion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correct IUD Placement 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.	Immediately post-insertion

Secondary Outcomes

Measure	Description	Time Frame
Correct IUD Placements 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.	4-6 weeks post-insertion
Patient Satisfaction with IUD Insertion

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18645075	Background	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. doi: 10.7863/jum.2008.27.8.1171.
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