Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2018-01-01
2020-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessing Pain and Effectiveness of Carevix Device for IUD Insertions
NCT07290517
Non Touch Technique for IUD Insertion
NCT02582281
Fast Versus Slow Tenaculum Placement
NCT02716636
Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures
NCT06193590
RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC
NCT02175030
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1: Traditional IUD Insertion
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.
No interventions assigned to this group
Arm 2: Simplified IUD Insertion
Simplified, investigational IUD insertion performed. No bimanual pelvic exam or uterine sounding.
Simplified IUD Insertion
IUD Insertion with no bimanual pelvic exam or uterine sounding.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Simplified IUD Insertion
IUD Insertion with no bimanual pelvic exam or uterine sounding.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Paul D Blumenthal
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul D Blumenthal, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Stanford University
References
Explore related publications, articles, or registry entries linked to this study.
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.
Padilla 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.
Maguire 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.
Canteiro 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.
Bahamondes 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.
Heinemann 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.
Christensen 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB-35138
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.