Cervical Lidocaine for Intrauterine Device Insertion Pain
NCT ID: NCT01411995
Last Updated: 2018-03-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2011-08-31
2011-12-31
Brief Summary
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Detailed Description
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Primary outcome: Pain reported on Visual Analog Scale (VAS) Intervention: 2% lidocaine gel at the tenaculum site and intracervical prior to intrauterine device placement
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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2% Lidocaine gel
Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal
2% lidocaine gel
3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to Intrauterine device insertion
Water based lubricant
Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal
Water based lubricant
3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to intrauterine device insertion
Interventions
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2% lidocaine gel
3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to Intrauterine device insertion
Water based lubricant
3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to intrauterine device insertion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* selecting intrauterine device contraception
* able and willing to consent
Exclusion Criteria
* current intrauterine device use
* expulsion of intrauterine device within 2 weeks
* allergy to lidocaine or water based lubricant
18 Years
45 Years
FEMALE
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Colleen P McNicholas, DO
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Division of Clinical Research at Washington University
St Louis, Missouri, United States
Countries
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References
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Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006 Jun;38(2):90-6. doi: 10.1363/psrh.38.090.06.
Kulier R, O'Brien PA, Helmerhorst FM, Usher-Patel M, D'Arcangues C. Copper containing, framed intra-uterine devices for contraception. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005347. doi: 10.1002/14651858.CD005347.pub3.
Rivera R, Best K. Current opinion: consensus statement on intrauterine contraception. Contraception. 2002 Jun;65(6):385-8. doi: 10.1016/s0010-7824(02)00304-9.
O'Brien PA, Kulier R, Helmerhorst FM, Usher-Patel M, d'Arcangues C. Copper-containing, framed intrauterine devices for contraception: a systematic review of randomized controlled trials. Contraception. 2008 May;77(5):318-27. doi: 10.1016/j.contraception.2007.12.011. Epub 2008 Mar 18.
Peipert JF, Zhao Q, Allsworth JE, Petrosky E, Madden T, Eisenberg D, Secura G. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011 May;117(5):1105-1113. doi: 10.1097/AOG.0b013e31821188ad.
Massey SE, Varady JC, Henzl MR. Pain relief with naproxen following insertion of an intrauterine device. J Reprod Med. 1974 Dec;13(6):226-31. No abstract available.
Madden T, Allsworth JE, Hladky KJ, Secura GM, Peipert JF. Intrauterine contraception in Saint Louis: a survey of obstetrician and gynecologists' knowledge and attitudes. Contraception. 2010 Feb;81(2):112-6. doi: 10.1016/j.contraception.2009.08.002. Epub 2009 Sep 16.
Buttram V, Izu A, Henzl MR. Naproxen sodium in uterine pain following intrauterine contraceptive device insertion. Am J Obstet Gynecol. 1979 Jul 1;134(5):575-8. doi: 10.1016/0002-9378(79)90844-5.
Hubacher D, Reyes V, Lillo S, Zepeda A, Chen PL, Croxatto H. Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen. Am J Obstet Gynecol. 2006 Nov;195(5):1272-7. doi: 10.1016/j.ajog.2006.08.022.
Dijkhuizen K, Dekkers OM, Holleboom CA, de Groot CJ, Hellebrekers BW, van Roosmalen GJ, Janssen CA, Helmerhorst FM. Vaginal misoprostol prior to insertion of an intrauterine device: an RCT. Hum Reprod. 2011 Feb;26(2):323-9. doi: 10.1093/humrep/deq348. Epub 2010 Dec 15.
Li YT, Kuo TC, Kuan LC, Chu YC. Cervical softening with vaginal misoprostol before intrauterine device insertion. Int J Gynaecol Obstet. 2005 Apr;89(1):67-8. doi: 10.1016/j.ijgo.2005.01.036. No abstract available.
Saav I, Aronsson A, Marions L, Stephansson O, Gemzell-Danielsson K. Cervical priming with sublingual misoprostol prior to insertion of an intrauterine device in nulliparous women: a randomized controlled trial. Hum Reprod. 2007 Oct;22(10):2647-52. doi: 10.1093/humrep/dem244. Epub 2007 Jul 25.
Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.
Other Identifiers
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201105067
Identifier Type: -
Identifier Source: org_study_id
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