Trial Outcomes & Findings for Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions (NCT NCT02220205)

NCT ID: NCT02220205

Last Updated: 2017-05-24

Results Overview

Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again. Sets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice

Results posted on

2017-05-24

Participant Flow

One participant voluntarily withdrew from the study due to time constraints which precluded completion of the study visit. Therefore, 60 participants enrolled and were randomized, and 59 completed the study.

Participant milestones

Participant milestones
Measure	PelvicSim Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes. PelvicSim	Manufacturer Model Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes. Manufacturer model
Overall Study STARTED	30	30
Overall Study COMPLETED	29	30
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PelvicSim Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes. PelvicSim	Manufacturer Model Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes. Manufacturer model
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PelvicSim n=29 Participants Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes. PelvicSim	Manufacturer Model n=30 Participants Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes. Manufacturer model	Total n=59 Participants Total of all reporting groups
Age, Continuous	26 years n=5 Participants	28 years n=7 Participants	27 years n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	30 participants n=7 Participants	59 participants n=5 Participants
Occupation Intern	8 participants n=5 Participants	12 participants n=7 Participants	20 participants n=5 Participants
Occupation Nurse practitioner student	21 participants n=5 Participants	18 participants n=7 Participants	39 participants n=5 Participants
Prior pelvic exams 0	10 exams n=5 Participants	5 exams n=7 Participants	15 exams n=5 Participants
Prior pelvic exams 1-5	10 exams n=5 Participants	10 exams n=7 Participants	20 exams n=5 Participants
Prior pelvic exams 6-10	2 exams n=5 Participants	6 exams n=7 Participants	8 exams n=5 Participants
Prior pelvic exams >10	7 exams n=5 Participants	9 exams n=7 Participants	16 exams n=5 Participants
Prior IUD insertions performed >=1	6 exams n=5 Participants	2 exams n=7 Participants	8 exams n=5 Participants
Prior IUD insertions performed 0	23 exams n=5 Participants	28 exams n=7 Participants	51 exams n=5 Participants

PRIMARY outcome

Timeframe: Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice

Outcome measures

Outcome measures
Measure	PelvicSim n=29 Participants Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes. PelvicSim	Manufacturer Model n=30 Participants Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes. Manufacturer model
Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice Pre-simulation	61.5 Percent of tasks performed correctly Interval 50.0 to 69.0	67.5 Percent of tasks performed correctly Interval 53.0 to 76.0
Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice Post-simulation	82.5 Percent of tasks performed correctly Interval 72.0 to 88.0	83 Percent of tasks performed correctly Interval 73.0 to 91.0
Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice Three month visit	65.5 Percent of tasks performed correctly Interval 58.0 to 75.0	67.5 Percent of tasks performed correctly Interval 59.0 to 76.0

SECONDARY outcome

Timeframe: Baseline to three months

Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale.

Outcome measures

Outcome measures
Measure	PelvicSim n=29 Participants Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes. PelvicSim	Manufacturer Model n=30 Participants Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes. Manufacturer model
Percent Change in Comfort Placing IUDs From Pre- to Post-insertion Copper IUD	89.3 Percent change in comfort	96.7 Percent change in comfort
Percent Change in Comfort Placing IUDs From Pre- to Post-insertion 52mg levonorgestrel IUD	92.9 Percent change in comfort	100 Percent change in comfort
Percent Change in Comfort Placing IUDs From Pre- to Post-insertion 13.5mg levonorgestrel IUD	89.3 Percent change in comfort	100 Percent change in comfort

Adverse Events

PelvicSim

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Manufacturer Model

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Siripanth Nippita

Beth Israel Deaconess Medical Center

Phone: 617-667-4165

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place