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OpenTrials
Completed

NCT Number: NCT03493815

A RCT of Ultrasound Guided IUD Insertion

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

(Visit 1) All interested women undergoing a scheduled IUD insertion will be screened for inclusion/exclusion criteria by the study coordinator or investigator prior to their clinic visit.

(Visit 2) After meeting eligibility criteria and being consented for the study, a subject will be ready to be randomized. Subject in both groups will fill out a visual analogue score (VAS) before and after the procedure grading their pain. Subjects will be instructed to call the investigator if they experience any abnormal uterine bleeding or problems with their IUD.

Subjects will then be randomized to one of two groups:

Group A: traditional blind IUD insertion. Group B: transabdominal ultrasound guided IUD insertion. Subjects will be randomized to either US guided or traditional placement of IUD using 1:1 allocation. The randomization scheme for this study will use variable-size, random permuted blocks where the variable block sizes are 2,4 and 6.

(Visit 3) Subjects will be scheduled to return to REI clinic 4-6 weeks (Visit 2) after insertion of the IUD as routine follow-up. Subjects will be asked about any adverse events. A routine string check in the form of a speculum exam will be performed in addition to a transvaginal ultrasound to confirm positioning of the IUD. If malposition is determined, then routine care will be to remove the IUD. The ultrasound operator will be blinded to the subject's arm in the study

(Visit 4) At 6 months subjects will be scheduled to return to REI clinic to have an IUD string check and if no strings are visualized then this will be categorized as malposition and the investigator will continue with routine care and work up Subjects who return to clinic for Visit 4 will also have a transvaginal ultrasound performed.

If the subject does not present for a clinic follow up, then she will be contacted by the Study Coordinator or investigator via phone to see if they still have their IUD in place (and when it was removed or lost).

All subjects will be surveyed for pain with the VAS and any adverse events (including abnormal uterine bleeding) will be recorded. All subjects will be asked to categorically rate their satisfaction with the IUD on a Likert Scale.

The total duration of the study is 6 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transabdominal Ultrasound Guided IUD Insertion

Procedure

Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion

Traditional Blind IUD Insertion

Procedure

Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion

Primary outcomes

  1. Number of Participants Who Had IUD Removed Within 6 Months

    Time frame: 6 Months

    IUD discontinuation rates during the 6-month post-insertion period

Secondary outcomes

  1. Number of Participants With Malpositioned IUD at 4-6 Week Visit

    Time frame: 4-6 Weeks Post Insertion String Check

    String check in the form of a speculum exam in addition to a transvaginal ultrasound to confirm positioning of the IUD

  2. Change in Pain Score

    Time frame: pre and post-insertion (both collected during the insertion visit)

    Pain was assessed pre and post-insertion with a visual analog scale (VAS) ranging from 0-10 with 0 being no pain and 10 being the worst. Change in pain score was calculated as post minus pre, hence the higher the number, the greater increase in pain.

  3. Number of Participants Satisfied With IUD at 6 Months

    Time frame: 6 Months

    Satisfaction with IUD was initially assessed using a 5-point likert scale where 1=not at all happy and 5=very happy. The likert scale was then collapsed to a binary outcome of satisfied (likert scale scores 4 and 5) vs. not satisfied (likert scale scores 1,2,3).

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

A Randomized Controlled Trial of Ultrasound-Guided Intrauterine Device (IUD) Insertion

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2018
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.