Simplified IUD Insertion Technique

Not Applicable

Withdrawn

• Conditions: Contraception
• Interventions: Procedure: Simplified IUD Insertion

• Registration Number: NCT02733081
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-11
• Study Start: 2018-01-01
• Primary Completion: 2020-10
• Study Completion: 2020-10
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Simplified IUD Insertion	Simplified IUD Insertion	Simplified, investigational IUD insertion performed. No bimanual pelvic exam or uterine sounding.

Primary Outcome Measures

Name	Time	Method
Correct IUD Placement Immediately Post-Insertion	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

Name	Time	Method
Patient Pain Scores (VAS)	Immediately Post-Insertion	Visual Analogue Scale (VAS)
Correct IUD Placements 4-6 Weeks Post-Insertion	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	Immediately Post-Insertion	Visual Analogue Scale (VAS)