Clinical trial NCT02733081: Simplified IUD Insertion Technique
Official title: Simplified IUD Insertion Technique: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Contraception
Keywords: Long Acting Reversible Contraception
Intrauterine Device (IUD)
Intrauterine Device (IUD) Insertion
Family Planning
International Family Planning
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Women 18 years and older presenting to contraceptive clinic in Gaborone, Botswana for IUD insertion and have ability to give informed consent.

Exclusion Criteria:

* Known contradictions to copper IUD, inability to comply with study protocol

Primary outcomes:
measure: Correct IUD Placement Immediately Post-Insertion
timeFrame: Immediately post-insertion
Secondary outcomes:
measure: Correct IUD Placements 4-6 Weeks Post-Insertion
timeFrame: 4-6 weeks post-insertion
measure: Patient Satisfaction with IUD Insertion
timeFrame: Immediately Post-Insertion
measure: Patient Pain Scores (VAS)
timeFrame: Immediately Post-Insertion
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Paul D Blumenthal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Christensen K, et al. Simplifying Insertion of IUD Devices. Selected for poster presentation at FIGO 2015, Vancouver British Columbia.
citation: 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.