N/A N=85 Randomized Diagnostic

A RCT of Ultrasound Guided IUD Insertion

IUD Not Visible

Bottom Line

View on ClinicalTrials.gov: NCT03493815 ↗

Enrolled (actual)

Serious AEs

1.2%

Results posted

May 2020

Primary outcome: Primary: Number of Participants Who Had IUD Removed Within 6 Months — 6; 8 Participants — p=0.51

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transabdominal Ultrasound Guided IUD Insertion (Procedure); Traditional Blind IUD Insertion (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Milton S. Hershey Medical Center
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Had IUD Removed Within 6 Months	6; 8	0.51
SECONDARY Number of Participants With Malpositioned IUD at 4-6 Week Visit	3; 6	0.41
SECONDARY Change in Pain Score	2.3; 2.1	0.76
SECONDARY Number of Participants Satisfied With IUD at 6 Months	24; 21	0.70

Summary

To determine the utility of ultrasound guided IUD insertion compared to the traditional blind insertion at an academic health institute where the skill level of the provider can vary greatly. We hypothesize that ultrasound-guided insertion will lead lower IUD discontinuation rates and greater patient satisfaction.

Eligibility Criteria

Inclusion Criteria

Undergoing IUD Insertion in an Office Setting
Fluent in Spoken and Written English
Premenopausal

Exclusion Criteria

Less than 6 Weeks Postpartum at Time of IUD Insertion
Intraoperative IUD Insertion
Pregnant
Prisoners
Cognitive Impairment
Unable to Read or Write

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Data sourced from ClinicalTrials.gov (NCT03493815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.