ContraceptionSIITNCT02733081
Simplified IUD Insertion Technique
A study testing Simplified IUD Insertion in people with Contraception, run by Stanford University.
Trial summary
This is a randomized controlled trial that compares traditional IUD insertion with that of a no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD placement is safe and effective without pre-procedural assessment of uterine size, direction, or depth. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Simplified IUD Insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to Oct 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years and older presenting to contraceptive clinic in Gaborone, Botswana for IUD insertion and have ability to give informed consent.
Who cannot join
- Known contradictions to copper IUD, inability to comply with study protocol
About this study
Official title: Simplified IUD Insertion Technique: A Randomized Controlled Trial
This is a randomized controlled trial that compares traditional IUD insertion with that of a no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD placement is safe and effective without pre-procedural assessment of uterine size, direction, or depth.
- Conditions
- Contraception
- Being tested
- Simplified IUD Insertion
- Keywords
- Long Acting Reversible Contraception, Intrauterine Device (IUD), Intrauterine Device (IUD) Insertion, Family Planning, International Family Planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified IUD InsertionProcedure or surgery
IUD Insertion with no bimanual pelvic exam or uterine sounding.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Traditional IUD Insertion | No intervention | Standard IUD insertion according to package insert. Bimanual pelvic exam to assess uterine size and position will be performed. Uterine sound will be used to measure depth of uterus prior to insertion. |
| Arm 2: Simplified IUD Insertion | Experimental | Simplified, investigational IUD insertion performed. No bimanual pelvic exam or uterine sounding. Receives: Procedure: Simplified IUD Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct IUD Placement Immediately Post-Insertion
Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at time of insertion as visualized by transvaginal ultrasound.
Measured: Immediately post-insertion
Secondary outcomes (3)
Correct IUD Placements 4-6 Weeks Post-Insertion
Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at 4-6 weeks after insertion as visualized by transvaginal ultrasound.
Measured: 4-6 weeks post-insertion
Patient Satisfaction with IUD Insertion
Visual Analogue Scale (VAS)
Measured: Immediately Post-Insertion
Patient Pain Scores (VAS)
Visual Analogue Scale (VAS)
Measured: Immediately Post-Insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study start1 Jan 2018
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul D Blumenthal, Stanford University
- Investigators
- Paul D Blumenthal, MD, MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733081
- Sponsor's protocol ID
- IRB-35138
- Acronym
- SIIT
- Status last verified
- Dec 2022
- First submitted
- 9 Feb 2016
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tayal VS, Crean CA, Norton HJ, Schulz CJ, Bacalis KN, Bliss S. Prospective comparative trial of endovaginal sonographic bimanual examination versus traditional digital bimanual examination in nonpregnant women with lower abdominal pain with regard to body mass index classification. J Ultrasound Med. 2008 Aug;27(8):1171-7. doi: 10.7863/jum.2008.27.8.1171.
PubMed 18645075Padilla LA, Radosevich DM, Milad MP. Limitations of the pelvic examination for evaluation of the female pelvic organs. Int J Gynaecol Obstet. 2005 Jan;88(1):84-8. doi: 10.1016/j.ijgo.2004.09.015.
PubMed 15617719Maguire K, Davis A, Rosario Tejeda L, Westhoff C. Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception. 2012 Sep;86(3):214-9. doi: 10.1016/j.contraception.2012.01.005. Epub 2012 Feb 9.
PubMed 22325115Canteiro R, Bahamondes MV, dos Santos Fernandes A, Espejo-Arce X, Marchi NM, Bahamondes L. Length of the endometrial cavity as measured by uterine sounding and ultrasonography in women of different parities. Contraception. 2010 Jun;81(6):515-9. doi: 10.1016/j.contraception.2010.01.006. Epub 2010 Mar 1.
PubMed 20472119Bahamondes MV, Monteiro I, Canteiro R, Fernandes Ados S, Bahamondes L. Length of the endometrial cavity and intrauterine contraceptive device expulsion. Int J Gynaecol Obstet. 2011 Apr;113(1):50-3. doi: 10.1016/j.ijgo.2010.10.013. Epub 2011 Jan 26.
PubMed 21272883Heinemann K, Reed S, Moehner S, Minh TD. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contraception.2015.01.007. Epub 2015 Jan 16.
PubMed 25601352Christensen K, et al. Simplifying Insertion of IUD Devices. Selected for poster presentation at FIGO 2015, Vancouver British Columbia.
ESHRE Capri Workshop Group. Intrauterine devices and intrauterine systems. Hum Reprod Update. 2008 May-Jun;14(3):197-208. doi: 10.1093/humupd/dmn003. Epub 2008 Apr 9.
PubMed 18400840
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified IUD Insertion Technique: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02733081
- Acronym / sponsor ID
- SIIT / IRB-35138
- Conditions
- Contraception
- Keywords
- Long Acting Reversible Contraception, Intrauterine Device (IUD), Intrauterine Device (IUD) Insertion, Family Planning, International Family Planning
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 11 Apr 2016 (estimated)
- 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.
This is a randomized controlled trial that compares traditional IUD insertion with that of a no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD placement is safe and effective without pre-procedural assessment of uterine size, direction, or depth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Traditional IUD Insertion | No intervention | –Standard IUD insertion according to package insert. Bimanual pelvic exam to assess uterine size and position will be performed. Uterine sound will be used to measure depth of uterus prior to insertion. |
| Arm 2: Simplified IUD Insertion | Experimental | Procedure: Simplified IUD InsertionSimplified, investigational IUD insertion performed. No bimanual pelvic exam or uterine sounding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women 18 years and older presenting to contraceptive clinic in Gaborone, Botswana for IUD insertion and have ability to give informed consent.
Key exclusion criteria (1 listed)
- Known contradictions to copper IUD, inability to comply with study protocol
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 |
|---|---|---|
| Simplified IUD InsertionIUD Insertion with no bimanual pelvic exam or uterine sounding. | Procedure or surgery | Arm 2: Simplified IUD Insertion |
Primary outcome
Correct IUD Placement Immediately Post-Insertion
Time frame: Immediately post-insertion
Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at time of insertion as visualized by transvaginal ultrasound.
3 secondary outcomes
Correct IUD Placements 4-6 Weeks Post-Insertion
Time frame: 4-6 weeks post-insertion
Patient Satisfaction with IUD Insertion
Time frame: Immediately Post-Insertion
Patient Pain Scores (VAS)
Time frame: Immediately Post-Insertion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Background: PubMed 18645075Tayal VS, Crean CA, Norton HJ, Schulz CJ, Bacalis KN, Bliss S. Prospective comparative trial of endovaginal sonographic bimanual examination versus traditional digital bimanual examination in nonpregnant women with lower abdominal pain with regard to body mass index classification. J Ultrasound Med. 2008 Aug;27(8):1171-7. doi: 10.7863/jum.2008.27.8.1171.
- Background: PubMed 15617719Padilla LA, Radosevich DM, Milad MP. Limitations of the pelvic examination for evaluation of the female pelvic organs. Int J Gynaecol Obstet. 2005 Jan;88(1):84-8. doi: 10.1016/j.ijgo.2004.09.015.
- Background: PubMed 22325115Maguire K, Davis A, Rosario Tejeda L, Westhoff C. Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception. 2012 Sep;86(3):214-9. doi: 10.1016/j.contraception.2012.01.005. Epub 2012 Feb 9.
- Background: PubMed 20472119Canteiro R, Bahamondes MV, dos Santos Fernandes A, Espejo-Arce X, Marchi NM, Bahamondes L. Length of the endometrial cavity as measured by uterine sounding and ultrasonography in women of different parities. Contraception. 2010 Jun;81(6):515-9. doi: 10.1016/j.contraception.2010.01.006. Epub 2010 Mar 1.
- Background: PubMed 21272883Bahamondes MV, Monteiro I, Canteiro R, Fernandes Ados S, Bahamondes L. Length of the endometrial cavity and intrauterine contraceptive device expulsion. Int J Gynaecol Obstet. 2011 Apr;113(1):50-3. doi: 10.1016/j.ijgo.2010.10.013. Epub 2011 Jan 26.
- Background: PubMed 25601352Heinemann K, Reed S, Moehner S, Minh TD. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contraception.2015.01.007. Epub 2015 Jan 16.
- BackgroundChristensen K, et al. Simplifying Insertion of IUD Devices. Selected for poster presentation at FIGO 2015, Vancouver British Columbia.
- Background: PubMed 18400840ESHRE Capri Workshop Group. Intrauterine devices and intrauterine systems. Hum Reprod Update. 2008 May-Jun;14(3):197-208. doi: 10.1093/humupd/dmn003. Epub 2008 Apr 9.
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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.
Paul D Blumenthal, MD, MPH principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Simplified IUD Insertion in people with Contraception, run by Stanford University.
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 1 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: withdrawn, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Correct IUD Placement Immediately Post-Insertion (time frame: Immediately post-insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02733081, which also lists 8 linked publications.
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 5 Dec 2022.