A RCT of Ultrasound Guided IUD Insertion
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 8, 2018 |
| End Date: | March 2021 |
| Contact: | Linda Li, MD |
| Email: | lindali@pennstatehealth.psu.edu |
| Phone: | 717-531-5394 |
A Randomized Controlled Trial of Ultrasound-Guided Intrauterine Device (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.
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.
(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. Team members that have REDCap access will access REDCap to
carry out the randomization assignment.
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 to ensure that the number of participants in each treatment arm is balanced
after each set of B randomized participants, where B is the block size.
(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.
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. Team members that have REDCap access will access REDCap to
carry out the randomization assignment.
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 to ensure that the number of participants in each treatment arm is balanced
after each set of B randomized participants, where B is the block size.
(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.
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
- Congnitive Impairment
- Unable to Read or Write
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