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A RCT of Ultrasound Guided IUD Insertion

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Penn State Health

Status

Completed

Conditions

IUD Not Visible

Treatments

Procedure: Transabdominal Ultrasound Guided IUD Insertion
Procedure: Traditional Blind IUD Insertion

Study type

Interventional

Funder types

Other

Identifiers

NCT03493815
STUDY00008432

Details and patient eligibility

About

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.

Full description

(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.

Enrollment

85 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

85 participants in 2 patient groups

Transabdominal Ultrasound Guided IUD Insertion
Experimental group
Description:
Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
Treatment:
Procedure: Transabdominal Ultrasound Guided IUD Insertion
Traditional Blind IUD Insertion
Active Comparator group
Description:
Traditional blind IUD insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
Treatment:
Procedure: Traditional Blind IUD Insertion

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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