N/A
Completed N=85
A RCT of Ultrasound Guided IUD Insertion
IUD Not Visible
Source: ClinicalTrials.gov NCT03493815 ↗
Enrolled (actual)
85
Serious AEs
1.2%
Results posted
May 2020
Primary outcomePrimary: Number of Participants Who Had IUD Removed Within 6 Months — 6; 8 Participants — p=0.51
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.
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 |
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
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. Informational only — not medical advice.