IUDNCT05700812
IUD Placement Without Sounding
A study testing Sound sparing levonorgestrel 52 mg IUD placement in people with IUD and IUD Insertion Complication, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility of a uterine sound sparing technique for levonorgestrel 52 mg intrauterine device (IUD) placement. This study will be conducted in three phases. In phase one, the IUD will be placed in standard fashion with a uterine sound to obtain baseline data. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD, IUD Insertion Complication, IUD; Complications
- What is being tested?
- Sound sparing levonorgestrel 52 mg IUD placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patients undergoing a levonorgestrel 52 mg IUD placement for contraception at a UC Davis outpatient clinic, who have signed consent for placement and are candidates for levonorgestrel 52 mg IUD placement based on the clinical judgement of their UC Davis Ob-Gyn provider.
Who cannot join
- Women with prior failed IUD placement
- Women with known uterine anomalies or uterine fibroids that distort the uterine cavity
- Women with known cervical stenosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Sacramento, California, 95817
About this study
Official title: Feasibility Study of IUD Placement Without Sounding
The purpose of this study is to determine the feasibility of a uterine sound sparing technique for levonorgestrel 52 mg intrauterine device (IUD) placement. This study will be conducted in three phases. In phase one, the IUD will be placed in standard fashion with a uterine sound to obtain baseline data. Phase two and three are interventional phases that will investigate IUD placement without the use of a uterine sound. In phase two, the IUD will be placed without the use of a uterine sound, but under abdominal ultrasound guidance. In phase three, the IUD will be placed without the use of a uterine sound and without ultrasound guidance. An ultrasound exam will be completed at the end of phase two and three to determine if the IUD was successful placed. To answer the secondary objectives, for all study phases the investigators will measure the procedure time, the participant-reported maximum pain during and 5-minutes post placement and the provider assessment of ease of placement. To determine the exploratory objective of IUD expulsion and perforation rate for a uterine sound sparing IUD placement technique, participants in phases two and three will complete a 30-day phone follow up and 90-day in clinic follow up to evaluate for IUD expulsion or perforation. The investigators hypothesize that the levonorgestrel 52 mg IUD can successfully be inserted without uterine sounding.
- Conditions
- IUD, IUD Insertion Complication, IUD; Complications
- Being tested
- Sound sparing levonorgestrel 52 mg IUD placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound sparing levonorgestrel 52 mg IUD placementProcedure or surgery
In phase one, the IUD will be placed in a standard fashion with the use of a uterine sound to obtain baseline data.
In the experimental phases of the study (phase 2 and 3) the levonorgestrel 52 mg IUD will be placed without the use of a uterine sound. In phase 2 the IUD will be placed under abdominal ultrasound guidance. In phase 3 the IUD will be placed without abdominal ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| IUD insertion study in three phases | Experimental | In phase one, the IUD will be placed in standard fashion with a uterine sound to obtain baseline data.
In phase two, the IUD will be placed without the use of a uterine sound and under abdominal ultrasound guidance.
In phase three, the IUD will be placed without the use of a uterine sound and without ultrasound guidance. Receives: Procedure: Sound sparing levonorgestrel 52 mg IUD placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful placement, defined by ultrasound confirmation, of a levonorgestrel 52 mg IUD placement without uterine sounding.
Successful placement without a uterine sound defined as ultrasound confirmation of IUD in the uterine cavity following placement. Outcomes will be compared between experimental phases two and three.
Measured: Ultrasound completed at end of IUD placement procedure to determine if successfully placed in the correct location.
Secondary outcomes (5)
Total time of IUD placement measured in minutes
Time measured from the start of the IUD inserter touching the cervix to the removal of the IUD inserter from the cervix in each of the three phases of the study. Outcomes will be compared for each of the three phases.
Measured: Measured once on day of IUD placement
Participant-reported maximum pain during IUD placement measured with a 100-mm visual analog scale
Participants will be handed a 100-mm visual analog scale and asked to mark their pain level. The assessment will be performed immediately following removal of IUD inserter and before the IUD thread is cut. Outcomes will be compared for each of the three phases.
Measured: Measured once on day of IUD placement
Participant-reported pain 5-minutes post IUD placement, meaured with a 100-mm visual analog scale
Participants will be handed a 100-mm visual analog scale and asked to mark their pain level. The assessment will be performed five minutes following removal of the speculum at the end of IUD placement procedure. Outcomes will be compared for each of the three phases.
Measured: Measured once on day of IUD placement
Provider assessment of ease of placement defined as an easy, moderate or difficult placement.
Providers placing the IUD will be asked to rate their assessment of the the ease of the IUD placement procedure as easy, moderate or difficult after completing IUD placement procedure. Outcomes will be compared for each of the three phases.
Measured: Measured once on day of IUD placement
IUD expulsion and perforation rate during first three months after placement with sound-sparing technique
An ultrasound exam will be completed on the day of the IUD placement to determine if the IUD is present in the uterine cavity and not perforated outside of the uterine cavity or expelled out of the uterine cavity. Outcomes will be reported for participants in phases two and three.
Measured: Measured at time of IUD insertion and three month clinic follow up three months after IUD placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Feb 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUDStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Three phase study. Phase one will only include gathering baseline data without intervention. Phases two and three each include a different intervention.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700812
- Sponsor's protocol ID
- 1952890
- Status last verified
- Jun 2023
- First submitted
- 22 Dec 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of IUD Placement Without Sounding
- ClinicalTrials.gov ID
- NCT05700812
- Acronym / sponsor ID
- 1952890
- Conditions
- IUD, IUD Insertion Complication, IUD; Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the feasibility of a uterine sound sparing technique for levonorgestrel 52 mg intrauterine device (IUD) placement. This study will be conducted in three phases. In phase one, the IUD will be placed in standard fashion with a uterine sound to obtain baseline data. Phase two and three are interventional phases that will investigate IUD placement without the use of a uterine sound. In phase two, the IUD will be placed without the use of a uterine sound, but under abdominal ultrasound guidance. In phase three, the IUD will be placed without the use of a uterine sound and without ultrasound guidance. An ultrasound exam will be completed at the end of phase two and three to determine if the IUD was successful placed. To answer the secondary objectives, for all study phases the investigators will measure the procedure time, the participant-reported maximum pain during and 5-minutes post placement and the provider assessment of ease of placement. To determine the exploratory objective of IUD expulsion and perforation rate for a uterine sound sparing IUD placement technique, participants in phases two and three will complete a 30-day phone follow up and 90-day in clinic follow up to evaluate for IUD expulsion or perforation. The investigators hypothesize that the levonorgestrel 52 mg IUD can successfully be inserted without uterine sounding.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Three phase study. Phase one will only include gathering baseline data without intervention. Phases two and three each include a different intervention.
| Arm | Type | Receives |
|---|---|---|
| IUD insertion study in three phases | Experimental | Procedure: Sound sparing levonorgestrel 52 mg IUD placementIn phase one, the IUD will be placed in standard fashion with a uterine sound to obtain baseline data. In phase two, the IUD will be placed without the use of a uterine sound and under abdominal ultrasound guidance. In phase three, the IUD will be placed without the use of a uterine sound and without ultrasound guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years
- Patients undergoing a levonorgestrel 52 mg IUD placement for contraception at a UC Davis outpatient clinic, who have signed consent for placement and are candidates for levonorgestrel 52 mg IUD placement based on the clinical judgement of their UC Davis Ob-Gyn provider.
Key exclusion criteria (3 listed)
- Women with prior failed IUD placement
- Women with known uterine anomalies or uterine fibroids that distort the uterine cavity
- Women with known cervical stenosis
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 |
|---|---|---|
| Sound sparing levonorgestrel 52 mg IUD placementIn phase one, the IUD will be placed in a standard fashion with the use of a uterine sound to obtain baseline data. In the experimental phases of the study (phase 2 and 3) the levonorgestrel 52 mg IUD will be placed without the use of a uterine sound. In phase 2 the IUD will be placed under abdominal ultrasound guidance. In phase 3 the IUD will be placed without abdominal ultrasound guidance. | Procedure or surgery | IUD insertion study in three phases |
Primary outcome
Successful placement, defined by ultrasound confirmation, of a levonorgestrel 52 mg IUD placement without uterine sounding.
Time frame: Ultrasound completed at end of IUD placement procedure to determine if successfully placed in the correct location.
Successful placement without a uterine sound defined as ultrasound confirmation of IUD in the uterine cavity following placement. Outcomes will be compared between experimental phases two and three.
5 secondary outcomes
Total time of IUD placement measured in minutes
Time frame: Measured once on day of IUD placement
Participant-reported maximum pain during IUD placement measured with a 100-mm visual analog scale
Time frame: Measured once on day of IUD placement
Participant-reported pain 5-minutes post IUD placement, meaured with a 100-mm visual analog scale
Time frame: Measured once on day of IUD placement
Provider assessment of ease of placement defined as an easy, moderate or difficult placement.
Time frame: Measured once on day of IUD placement
IUD expulsion and perforation rate during first three months after placement with sound-sparing technique
Time frame: Measured at time of IUD insertion and three month clinic follow up three months after IUD placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound sparing levonorgestrel 52 mg IUD placement in people with IUD and IUD Insertion Complication, run by University of California, Davis 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 2 inclusion and 3 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 7 Aug 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Successful placement, defined by ultrasound confirmation, of a levonorgestrel 52 mg IUD placement without uterine sounding. (time frame: Ultrasound completed at end of IUD placement procedure to determine if successfully placed in the correct location.). 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 7 Aug 2024.