Simplified IUD Insertion Technique

Stanford University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Contraception

Interventions

Simplified IUD InsertionPROCEDURE

IUD Insertion with no bimanual pelvic exam or uterine sounding.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Immediately post-insertion

Secondary Outcomes

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.

Time frame: 4-6 weeks post-insertion

Patient Satisfaction with IUD Insertion

Visual Analogue Scale (VAS)

Time frame: Immediately Post-Insertion

Patient Pain Scores (VAS)

Visual Analogue Scale (VAS)

Time frame: Immediately Post-Insertion

Data from ClinicalTrials.gov

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