Contraceptive Devices, IntrauterineNCT02220205
Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions
A study testing PelvicSim and Manufacturer model in people with Contraceptive Devices, Intrauterine and Education, Medical, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In order to make them accessible to women, health care providers must be trained to insert them. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Devices, Intrauterine, Education, Medical
- What is being tested?
- PelvicSim and Manufacturer model
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- First-year residents in obstetrics and gynecology or family medicine, or student in physician assistant or nurse practitioner training programs
- Trainees who have performed <5 intrauterine device insertions
- Trainees who plan to provide intrauterine devices in their clinical practice
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In order to make them accessible to women, health care providers must be trained to insert them. Physicians, physician assistant, and nurse practitioners often learn how to do so by first learning about IUDs, then practicing on a model that the IUD manufacturer provides.
Educators have recently been using more sophisticated models to teach clinical skills such as surgical procedures. We are investigating whether these models may be more useful in teaching IUD insertion.
- Being tested
- PelvicSim, Manufacturer model
- Keywords
- IUD, training, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PelvicSimOther
Manufacturer modelDevice
| Study group | Role | What they receive |
|---|---|---|
| PelvicSim | Active comparator | Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes. Receives: Other: PelvicSim |
| Manufacturer model | Placebo comparator | Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes. Receives: Device: Manufacturer model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice
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.
Measured: Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice
Secondary outcomes (1)
Percent Change in Comfort Placing IUDs From Pre- to Post-insertion
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.
Measured: Baseline to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Contraceptive Devices, IntrauterineStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siripanth Nippita, Beth Israel Deaconess Medical Center
- Investigators
- Siripanth Nippita, MD, MS, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220205
- Sponsor's protocol ID
- 2014P-000106
- Status last verified
- Apr 2017
- First submitted
- 14 Aug 2014
- Last updated
- 24 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions
- ClinicalTrials.gov ID
- NCT02220205
- Acronym / sponsor ID
- 2014P-000106
- Keywords
- IUD, training, simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Posted 24 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In order to make them accessible to women, health care providers must be trained to insert them. Physicians, physician assistant, and nurse practitioners often learn how to do so by first learning about IUDs, then practicing on a model that the IUD manufacturer provides.
Educators have recently been using more sophisticated models to teach clinical skills such as surgical procedures. We are investigating whether these models may be more useful in teaching IUD insertion.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PelvicSim | Active comparator | Other: PelvicSimParticipants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes. |
| Manufacturer model | Placebo comparator | Device: Manufacturer modelParticipants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- First-year residents in obstetrics and gynecology or family medicine, or student in physician assistant or nurse practitioner training programs
- Trainees who have performed <5 intrauterine device insertions
- Trainees who plan to provide intrauterine devices in their clinical practice
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PelvicSim | Other | PelvicSim |
| Manufacturer model | Device | Manufacturer model |
Primary outcome
Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice
Time frame: Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice
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.
1 secondary outcome
Percent Change in Comfort Placing IUDs From Pre- to Post-insertion
Time frame: Baseline to three months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siripanth Nippita, MD, MS principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PelvicSim and Manufacturer model in people with Contraceptive Devices, Intrauterine and Education, Medical, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice (time frame: Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.